Contents...permanent organized documented records for all safety reports. The person ensures compliance with local regulations and company`s Global ... PSUR Periodic Safety Update

h

Contents 1. Introduction and Contacts..….……….…….P.1

2. Qualifications Pack……….………………........P.2

3. Glossary of Key Terms ….……………..........P.5

4. NOS Units………………………..….……..………..P.7

5. Annexure: Nomenclature for QP & OS..P.26

6. Assessment Criteria ……………………………P.28

Introduction

What are Occupational Standards (OS)? ➢ OS describe what

individuals need to do, know and understand in order to carry out a particular job role or function

➢ OS are

performance standards that individuals must achieve when carrying out functions in the workplace, together with specifications of the underpinning knowledge and understanding

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Qualifications Pack- Pharmacovigilance Associate

SECTOR: LIFE SCIENCES

SUB-SECTOR: PHARMACEUTICAL, BIO PHARMACEUTICAL, CONTRACT RESEARCH

OCCUPATION: PHARMACOVIGILANCE

REFERENCE ID: LFS/Q0702

ALIGNED TO: NCO-2015- 2212.9900

Brief Job Description: Pharmacovigilance associate is responsible for the collection of information on Adverse Drug Reactions (ADR)/ Adverse Event (AE) and filing of Individual Case Safety Report (ICSR). He/she follows up, processes and submit expedited report. The individual is responsible for preparation and submission of Periodic Safety Update Report (PSUR).The person is also expected to render support in development of Risk Management Plan (RMP) and Pharmacovigilance System Master File (PSMF).He/she is also responsible for Global and local Literature Surveillance using literature databases (e.g. PubMed, Embase).This individual is involved in maintenance of safety database and permanent organized documented records for all safety reports. The person ensures compliance with local regulations and company`s Global Pharmacovigilance requirements.

Personal Attributes: The individual should be highly process driven with excellent attention to detail and time management; have good writing, reading and computer skills. He/she should be able to comprehend situations and have good communication skills. The person should demonstrate the ability to prioritize tasks effectively and get along with people and function well within an interdependent team. S/he should be focused on quality, compliance and teamwork.

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Introduction

QUALIFICATIONS PACK - OCCUPATIONAL STANDARDS FOR LIFE SCIENCES INDUSTRY

Qualifications Pack for Pharmacovigilance Associate

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Qualifications Pack Code LFS/Q0702

Job Role Pharmacovigilance Associate

Credits (NSQF) TBD Version number 1.0

Industry Life Sciences Drafted on 01/10/18

Sub-sector

Pharmaceutical, Biopharmaceutical and Contract Research

Last reviewed on 16/08/19

Occupation Pharmacovigilance Next review date 01/08/23

NSQC Clearance on

Job Role Pharmacovigilance Associate

Role Description

The person is responsible for identifying /reporting Adverse Events (AEs) / Product Quality Complaints (PQC) associated with AEs (Adverse Events) to Regulatory Authority(ies) as per the local regulatory reporting requirements

NSQF level Minimum Educational Qualifications

4

Graduate in Life Sciences subjects/ Pharma / Biotechnology/ Nursing

Prerequisite License or Training

Not Applicable

Minimum Job Entry Age 20 Years

Experience

Applicable National Occupational Standards (NOS)

Compulsory: 1. LFS/N0701: Perform collection, processing and assessment of

Individual Case Study Reports (ICSRs)

2. LFS/N0702: Use softwares for various Pharmacovigilance activities

3. LFS/N0703: Ensure Regulatory compliance

4. LFS/N0704: Coordinate with relevant internal and external

stakeholders

Job

Det

ails


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Performance Criteria As described in the relevant NOS units


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Keywords /Terms Description

Core Skills/Generic Skills

Core Skills or Generic Skills are a group of skills that are key to learning and working in today's world. These skills are typically needed in any work environment. In the context of the NOS, these include communication related skills that are applicable to most job roles.

Description Description gives a short summary of the unit content. This would be helpful to anyone searching on a database to verify that this is the appropriate NOS they are looking for.

Function

Function is an activity necessary for achieving the key purpose of the sector, occupation, or area of work, which can be carried out by a person or a group of persons. Functions are identified through functional analysis and form the basis of NOS.

Job role

Job role defines a unique set of functions that together form a unique employment opportunity in an organisation.

Knowledge and Understanding

Knowledge and Understanding are statements, which together specify the technical, generic, professional and organisational specific knowledge that an individual need in order to perform to the required standard.

National Occupational Standards (NOS)

NOS are Occupational Standards, which apply, uniquely in the Indian context.

Occupation

Occupation is a set of job roles, which perform similar/related set of functions in an industry.

Organisational Context

Organisational Context includes the way the organisation is structured and how it operates, including the extent of operative knowledge managers have of their relevant areas of responsibility.

Performance Criteria

Performance Criteria are statements that together specify the standard of performance required when carrying out a task.

Qualifications Pack (QP)

Qualifications Pack comprises the set of NOS, together with the educational, training and other criteria required to perform a job role. A Qualifications Pack is assigned a unique qualification pack code.

Qualifications Pack Code

Qualifications Pack Code is a unique reference code that identifies a qualifications pack.

Scope

Scope is the set of statements specifying the range of variables that an individual may have to deal with in carrying out the function which have a critical impact on the quality of performance required.

Sector Sector is a conglomeration of different business operations having similar businesses and interests. It may also be defined as a distinct subset of the economy whose components share similar characteristics and interests.

Def

init

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Sub-Sector Sub-sector is derived from a further breakdown based on the characteristics and interests of its components.

Sub-functions

Sub-functions are sub-activities essential to fulfil the achieving the objectives of the function.

Technical Knowledge

Technical Knowledge is the specific knowledge needed to accomplish specific designated responsibilities.

Unit Code

Unit Code is a unique identifier for an NOS unit, which can be denoted with an ‘N’.

Unit Title

Unit Title gives a clear overall statement about what the incumbent should be able to do.

Vertical

Vertical may exist within a sub-sector representing different domain areas or the client industries served by the industry.

Keywords /Terms Description

NOS National Occupational Standard(s)

NSQF National Skill Qualifications Framework

NCO-2015 National Classification of Occupations-2015

OS Occupational Standard(s)

QP Qualifications Pack

AE Adverse Event

ADR Adverse Drug Reactions

SOP Standard Operating Procedures

ICSRs Individual Case Study Reports

RMP Risk Management Plan

PSMF Pharmacovigilance System Master File

PSUR Periodic Safety Update Report

GVP Good Pharmacovigilance Practices

PvPI Pharmacovigilance Program of India

CAPA Corrective Action Preventive Action

BCP Business Continuity Planning

AMCs Adverse Drug Reaction Monitoring Centres

Acr

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yms

LFS/N0701: Perform collection, processing and assessment of Individual Case Study Reports (ICSRs)

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Overview

This Occupational Standard describes the knowledge, understanding and skills required for a Pharmacovigilance Associate to collect, process and assess the Individual Case Study Reports (ICSRs).

National Occupational

Standards


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Unit Code LFS/N0701

Unit Title (Task)

Perform collection, processing and assessment of Individual Case Study Reports (ICSRs)

Description This NOS gives an overview how a Pharmacovigilance Associate performs the collection, processing and assessment of the Individual Case Study Reports (ICSRs)

NSQF Level 4

Scope

The unit/task covers the following:

• Data Collection of ICSR's

• Processing of ICSR and Triage

• Reporting of ICSR

Performance Criteria (PC) w.r.t. the Scope

Element


Data Collection of ICSR’s

To be competent, the user/individual on the job must be able to: PC1. collect data from solicited sources (Patient registries, Interventional and non-

interventional studies, post-approval compassionate use programs, name patient programs (Pre-approval) etc.) and unsolicited sources (Regulatory reports, Literature Reports, Spontaneous Reports from healthcare professional/consumer, Internet/digital media etc.,) to strengthen spontaneous reporting of ADRs

PC2. perform literature monitoring of pharmaceutical products by using electronic literature database or offline literature to identify ICSR and other safety related information in compliance with Company’s policies and local Pharmacovigilance requirements for the same

PC3. follow-up regularly to obtain additional information relevant to the case as necessary to provide a complete description of the safety event

PC4. handle the calls as required if deputed in drug safety call centres

Processing of ICSR and Triage

PC5. record the date of receipt for each ADR from initial notification to follow-up communication

PC6. record the date first valid (Day Zero/ Clock start date- considered the day on which the minimum criteria like patient information, suspect drug, AE/ADR , reporter details for a reportable ICSR is fulfilled )

PC7. perform duplicate check of ICSR PC8. check whether the case is medically confirmed PC9. ensure that the patient’s confidentiality and privacy in accordance with local

applicable laws and regulations are adhered to and if necessary, performed by redaction of patient

PC10. perform triage prioritization of 15-day cases PC11. perform data entry for ICSRs into safety databases and coding of relevant

medical terminologies using MedDRA dictionary PC12. write case narrative in chronological order PC13. maintain source documents as per Good Pharmacovigilance Practices (GVP)

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Reporting of ICSR PC14. interpret all the validated new information from appropriate sources PC15. perform ICSR reporting by including essential data elements like patient

information, reporter details, suspected reaction and suspected medications PC16. submit expedited reports within given time frame to meet the regulatory

reporting timelines PC17. classify special population cases using pharmaceutical products

Knowledge and Understanding (K)

A. Organisational Context (Knowledge of the Company/ Organisation and its processes)

The user/individual on the job needs to know and understand: KA1. data collection procedure of company KA2. ICSR related Standard Operating Procedures (SOPs) KA3. SOP on case processing, writing case narratives and MedDRA coding KA4. procedures for reporting data KA5. escalation procedures KA6. quality management SOPs including those for change control, deviations and

Corrective Action Preventive Action (CAPA) and Business continuity planning (BCP)

KA7. security, privacy, data protection, IT policies and integrity policies of organization

B. Technical Knowledge

The user/individual on the job needs to know and understand: KB1. general principles of pharmacology KB2. PVPI, ICH and WHO guidelines for adverse event reporting KB3. GCP guidelines and GVP Modules KB4. utilization of MedDRA and WHO drug dictionary KB5. method of writing case narratives and medical writing KB6. tools and methods of literature search (e.g. PubMed) KB7. tools and software for ICSR report generation (e.g. Argus, ArisG) KB8. functioning of EudraVigilance KB9. PV guidelines and regulatory requirement of USFDA, EMA, CDSCO, UKMHRA,

Health Canada and other international regulators KB10. changes/new regulations affecting pharmacovigilance activities

Skills (S)

A. Core Skills/ Generic Skills

Writing skills

The user/ individual on the job needs to know and understand how to: SA1. record and communicate details of work done to appropriate people using

written/typed report or computer-based record/electronic mail SA2. use computers, internet, software tools to write the case narratives Reading skills

The user/individual on the job needs to know and understand how to: SA3. read and interpret the various coding systems as per company norms, GCP,

GVP, Volume 9A, Volume 10, CIOMS, ICH E2B, E2C, E2D, E2F, M4, M1 and WHO guidelines


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Oral Communication (Listening and Speaking skills)

The user/individual on the job needs to know and understand how to: SA4. disclose information only to those who have the right and need to know it and

maintain confidentiality SA5. practice professional telephone etiquette SA6. practice strong verbal and interpersonal communication skills SA7. communicate new or changed regulations to relevant members of the

department to initiate any change in process SA8. use verbal communication etiquette to build and maintain good relationships

across functional units and company affiliates

B. Professional Skills

Decision making

The user/individual on the job needs to know and understand how to: SB1. make decisions to write case narratives in compliance to the regulations and

guidelines

Plan and Organise

The user/individual on the job needs to know and understand how to: SB2. practice strong organization and prioritization skills for handling administrative

and data entry duties simultaneously SB3. plan work assigned on a daily basis and provide estimates of time required for

each piece of work SB4. adapt to meet work timelines

Problem solving

The user/individual on the job needs to know and understand how to: SB5. seek clarification on problems from others SB6. use effective problem-solving techniques SB7. escalate critical items or any other issue deemed necessary to concerned

managers/ clients

Critical thinking

The user/individual on the job needs to know and understand how to: SB8. apply, analyse and evaluate information to define action steps SB9. apply balanced judgments to different approaches SB10. analyse the depth of the issue and apply a proactive approach Analytical Thinking

The user/individual on the job needs to know and understand how to: SB11. identify the data points which needs to be queried to reporter or local safety

officer

Customer Centricity

The user/individual on the job needs to know and understand how to:


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SB12. keep customer guidelines, instructions and the related regulatory requirement in focus while writing ICSR

SB13. liaise effectively and maintain excellent relationship with the internal/ external contacts


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NOS Version Control

NOS Code LFS/N0701



Industry Sub-sector Pharmaceutical, Biopharmaceutical and Contract Research



LFS/N0702: Use softwares for various Pharmacovigilance activities

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Standards

Overview This Occupational Standard describes the knowledge, understanding and skills required in a Pharmacovigilance Associate to use softwares for various Pharmacovigilance activities.


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Unit Code LFS/N0702

Unit Title (Task)

Use softwares for various Pharmacovigilance activities

Description This NOS gives an overview about the use of softwares for various Pharmacovigilance activities by Pharmacovigilance Associate

NSQF Level 4

Scope

The unit/task covers the following:

• Coding using MedDRA Dictionary, WHO Drug Dictionary and Medical terminologies

• Study of Drug Safety Databases like Argus, ArisGlobal, Safety Easy (AB Cube)

• Working with Pharmacovigilance Databases


Element


Coding using MedDRA Dictionary, WHO Drug Dictionary and Medical terminologies

To be competent, the user/individual on the job must be able to:

PC1. use MedDRA software tools PC2. conduct medical coding of adverse events by using appropriate MedDRA code

to ensure accuracy of label AE assessments PC3. utilize MedDRA coding according to ICH (International Conference on

Harmonization) guidelines while coding an adverse event PC4. deliver outcomes using MedDRA in Clinical trial databases, Investigator’s

Brochures, Core Safety Information, Safety summaries, Clinical Study Reports, ICSRs, PSURs and product labelling

PC5. generate line listing and summary tabulation

Study of Drug Safety Databases like Argus, ArisGlobal, Safety Easy (AB Cube)

PC6. use relevant software tools to support the entry, classification, coding and assessment of adverse event reports, in accordance with international standards and guidelines

PC7. manage reports from all potential sources, including spontaneous, literature and clinical trial safety reports, to support blinded clinical trials and other specific business processes and SOPs

PC8. facilitate compliance with domestic and global safety reporting obligations for drugs, vaccines, biologics, devices and combination products

PC9. assist in delivering automated global case processing, periodic reporting, E2B intake and submission, comprehensive reporting, detailed analytics and safety operations from within a single system

PC10. assist in specific actions and monitor response timeframes for all key activities such as data entry, assessment, coding and reporting for full compliance

PC11. explain wide range ICSR reports including expedited (serious reports, at risk reports), non-expedited reports and aggregate reports to aid in global adverse event reporting, including the national and other international adverse reporting forms and aggregate report templates

PC12. develop matrix of continuous flow and submission of cases

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Working with

Pharmacovigilance

Databases

PC13. check for software tools’ validation (IQ, OQ & PQ) before using the software tool or databases and perform labelling of ADRs against the approved company labels

PC14. perform manual data entry from ADR paper forms with support from integrated international terminologies (latest versions) such as WHO Drug and MedDRA

PC15. comply with the international ICH E2B standard and support quality review of cases processed and report scheduling

PC16. support the domestic collection and processing of individual case safety report (ICSR) data, and its sharing of reports

PC17. perform post marketing surveillance at the sponsor site, CRO site, hospitals, AMCs (Adverse Drug Reaction Monitoring Centres) to store the safety profile and adverse event reports of the drug



The user/individual on the job needs to know and understand: KA1. IT policies of company KA2. data integrity related SOPs KA3. SOP for accessing the computer systems and emails KA4. procedures for reporting data, escalation procedures KA5. quality management SOPs including those for change control, deviations and

CAPAs and BCP


The user/individual on the job needs to know and understand: KB1. operating procedure of software like MedDRA, WHO Drug dictionary, SAS,

Drug Safety Database like Argus and ArisGlobal, Safety Easy (AB Cube), EudraVigilance and ADR reporting software like VigiFlow and VigiBase

KB2. GCP guidelines and ICH E2B standard KB3. how to improve the typing speed KB4. method of writing case narratives and medical writing KB5. tools and methods of literature search KB6. process flow and forms of ADR reporting reports KB7. artificial intelligence future software validation tools (IQ, OQ & PQ) as well as

about artificial intelligence KB8. changes/new regulations affecting pharmacovigilance activities KB9. assessment of Vaccine Adverse Event Reporting System (VAERS) KB10. recall International Classification of Diseases (ICD) codes for drugs

Skills (S)


Writing skills

The user/ individual on the job needs to know and understand how to:

SA1. draft letters pertaining to AEs and write detailed reports for pharmacovigilance reporting

SA2. record and communicate details of work done to appropriate people using

written/typed report or computer-based record/electronic mail

SA3. use computers, internet, software tools for pharmacovigilance related work


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Reading skills

The user/individual on the job needs to know and understand how to: SA4. read and interpret various coding systems, medical terminology as per company

norms, GCP, PVPI and WHO guidelines SA5. read notes/comments from supervisors


The user/individual on the job needs to know and understand how to: SA6. disclose information only to those who have the right and need to know it SA7. maintain confidentiality of sensitive information SA8. communicate new or changed regulations to relevant members of the

department to initiate any change in process SA9. build and maintain good relationships across functional units and company

affiliates


Analytical Thinking

The user/individual on the job needs to know and understand how to: SB1. analyse data and information for preparing reports SB2. pay attention to detail SB3. identify anomalies in data SB4. suggest improvements (if any) in process/formats for reports/documentation

based on experience and observation SB5. use available data and computer software to create required documentation

Decision making

The user/individual on the job needs to know and understand how to: SB6. make decisions on a suitable course of action or response SB7. make decisions to write case narratives in compliance to the regulations and

guidelines

Plan and Organize

The user/individual on the job needs to know and understand how to: SB8. plan and organize assigned work in order to achieve specified deadlines SB9. multi-task and adapt to meet work timelines SB10. effectively interact with the various stakeholders to complete assigned tasks

Critical Thinking

The user/individual on the job needs to know and understand how to: SB11. evaluate the drafted reports in line to data integrity rules SB12. critically assess the terms/ medical codes for preparing the report

Problem Solving



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SB13. take help of IT team in case of any login related issues SB14. escalate critical items or any other issue deemed necessary to concerned

managers/ clients

Customer Centricity

The user/individual on the job needs to know and understand how to: SB15. keep customer guidelines, instructions and the relevant regulatory guidelines in

focus while reporting the ADR SB16. ensure data integrity and confidentiality while entering information SB17. liaise effectively and maintain excellent relationship with the internal/external

contacts


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NOS Version Control

NOS Code LFS/N0702

Credits(NSQF) TBD Version number 1.0





LFS/N0703: Ensure regulatory compliance

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Standards

Overview

This Occupational Standard is about the knowledge, understanding and skills required by a Pharmacovigilance Associate to ensure regulatory compliance.


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Unit Code LFS /N0703

Unit Title (Task)

Ensure regulatory compliance

Description This NOS unit discusses about the procedures followed by Pharmacovigilance Associate for ensuring regulatory compliance

NSQF Level 4

Scope

This unit / task covers the following:

• Compile and review the regulatory compliance of ICSRs • Identifying and resolving any issues hampering the regulatory compliance

• Improving regulatory compliance

Performance Criteria (PC) w.r.t the Scope

Element


Compile and review the regulatory compliance of ICSRs

To be competent, you must be able to:

PC1. ensure timely submission of ICSRs, PSUR, RMP, Signal reports and aggregate reports as per the respective Regulatory Authority submission timeline

PC2. ensure appropriate processes are in place to comply with the respective Regulatory Authority requirement

PC3. review the accuracy of reports on a regular basis to comply with the existing Regulatory requirements and perform the receipt and evaluation of safety data exchange agreements (as applicable)

PC4. ensure that the reports are submitted to regulatory authorities within timelines

Identifying and resolving any issues hampering the regulatory compliance

PC5. take corrective action in response to non-compliance of reports PC6. initiate investigation for the deviations PC7. identify the root cause of the deviation, take corrective and preventive actions

and provide adequate trainings. (if required) PC8. ensure appropriate documentation of these corrective and preventive actions

Improving regulatory compliance

PC9. maintain awareness about current regulatory trends and practices. PC10. incorporate continuous improvements into Pharmacovigilance processes and

policies based on existing Global and Local Regulatory Pharmacovigilance requirements

PC11. participate in regulatory inspection/ internal and client audit



The user/individual on the job needs to know and understand: KA1. IT rules and policies of company

KA2. data integrity related SOPs

KA3. SOP for accessing the computer systems and emails

KA4. procedures for reporting of faulty system or software problems

KA5. escalation procedures

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KA6. quality management SOPs including those for change control, deviations and

CAPAs and BCP

B Technical Knowledge

The user/individual on the job needs to know and understand: KB1. operating procedure of software like MedDRA, WHO Drug dictionary, SAS,

Drug Study Database like Argus and ArisGlobal, ADR reporting software like

VigiFlow, VigiBase

KB2. GCP guidelines and ICH E2B standard

KB3. computer handling (MS Word, Excel, Power Point Presentation, Outlook and

Skype)

KB4. software validation procedures

KB5. changes/new regulations affecting pharmacovigilance activities

Skills (S)


Writing skills

The user/individual on the job needs to know and understand how to: SA1. complete accurate and well written work with attention to detail SA2. record and communicate details of work done to appropriate people using

written/typed report or computer-based record/electronic mail SA3. use computers, internet, software tools ONLY for pharmacovigilance related

work

Reading skills

The user/individual on the job needs to know and understand how to: SA4. read instructions, guidelines, procedures, rules and service level agreements SA5. understand the various coding systems, software terminology as per company

norms, GCP, GVP, PVPI and WHO guidelines


The user/individual on the job needs to know and understand how to: SA6. communicate with IT infrastructure and QA team SA7. disclose information only to those who have the right and need to know it and

maintain confidentiality SA8. communicate new or changed regulations to relevant members of the

department to initiate any change in process SA9. build and maintain good relationships across functional units and company

affiliates


Decision making

The user/individual on the job needs to know and understand how to: SB1. make decisions on suitable courses of action SB2. make decisions to use the software which are in compliance to the regulations

and guidelines

Plan and Organise


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The user/individual on the job needs to know and understand how to: SB3. plan and organize your work to meet timelines and work requirement and

regulatory standards

Problem solving

The user/individual on the job needs to know and understand how to: SB4. apply problem solving approaches in different situations SB5. take help of IT team in case of any computer infrastructure and software

related issues Analytical thinking

The user/individual on the job needs to know and understand how to: SB6. analyse data and activities SB7. analyse the regulatory requirement of the relevant country before compiling

the report

Critical thinking

The user/individual on the job needs to know and understand how to: SB8. apply balanced judgments to different situations SB9. ensure data integrity and confidentiality Customer Centricity

The user/individual on the job needs to know and understand how to: SB10. keep the relevant regulatory guidelines in mind while using computer systems SB11. liaise effectively and maintain excellent relationship with the internal/external

contacts


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NOS Version Control

NOS Code LFS/N0703

Credits(NSQF) TBD Version number 1.0





LFS/N0704: Coordinate with relevant internal and external stakeholders

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Overview

This Occupational Standard describes the knowledge, understanding and skills required in a Pharmacovigilance Associate to coordinate with Medical Coder/ Reviewer, Safety Physicians, Supervisors and Cross-Functional teams and auditors.


Standards


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Unit Code LFS/N0704

Unit Title (Task)

Coordinate with relevant internal and external stakeholders

Description This NOS unit gives an overview how a Pharmacovigilance Associate coordinates with relevant internal and external stakeholders

NSQF Level 4

Scope

This unit/task covers the following:

• Coordination with internal team members

• Coordination with Cross- Functional Team

• Respond to audit queries


Element


Coordination with internal team members

To be competent, the user/individual on the job must be able to: PC1. ask queries to the relevant team members to understand the work output

requirements PC2. perform a self-run quality check for the cases in coordination with team

members, while routing it to the medical reviewer for next workflow PC3. co-ordinate with various stakeholders in the team for resolution of queries while

ensuring the completeness and accuracy of the information entered into the database for all the cases, especially while working on Suspected Unexpected Serious Adverse Reaction or fatal cases for smooth workflow

PC4. inform supervisor on issues requiring intervention PC5. deliver quality work on time and report any anticipated reasons for delays in the

timelines to the concern teams and stakeholders PC6. seek the information from the supervisor relevant to escalated issues and their

solutions PC7. ensure compliance with company policies and rule PC8. provide support to Pharmacovigilance scientist/in-charge or supervisor in

establishment /upgradation of pharmacovigilance system as and when required related to communication escalations for any co-ordination related activity

Coordination with Cross- Functional Team

PC9. coordinate with medical affairs team to maintain Medical Information System (MEDINFO)

PC10. impart training to team members/cross-function team members PC11. coordinate with medical review team for a smooth workflow PC12. support patient support program associate/ data assistant in mining spontaneous

reports submitted to national surveillance systems

Respond to audit queries

PC13. interact with auditors in a language he/she is comfortable with PC14. explain the query clearly and provide response to the auditor PC15. produce the documented records for activities performed PC16. maintain data integrity while responding to auditors


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The user/individual on the job needs to know and understand: KA1. organizational SOPs and policies on preferred language of communication,

reporting and escalation policy, quality delivery standards, and personnel management clinical research team reporting structure

KA2. employment rules and data integrity rules KA3. reporting structure and escalation matrix KA4. types of audits KA5. quality management SOPs including those for change control, deviations and

CAPAs and BCP


The user/individual on the job needs to know and understand: KB1. compliance related documentation KB2. ADR reporting procedures KB3. SOP for use of various software for pharmacovigilance work KB4. job role boundaries of pharmacovigilance associate KB5. GMP, GCP, PVPI, WHO guidelines KB6. ways of communication and interpersonal skills KB7. development of technical procedures KB8. installation/validation of database or other tools KB9. development of PSMF KB10. Quality Management System (QMS) KB11. felicitation in registering QPPV/PvOI KB12. MEDINFO system KB13. Service Level Agreement (SLA) KB14. GVP, GCP, PVPI, ICH, CIOMS guidelines KB15. changes /new regulations affecting pharmacovigilance activities

Skills (S)


Writing skills

The user/ individual on the job needs to know and understand how to:

SA1. write mails, monitoring reports and documents, letters in English language with sensitivity towards cross cultural differences

SA2. record and communicate details of work done to appropriate people using

written/typed report or computer-based record/electronic mail

Reading skills

The user/individual on the job needs to know and understand how to: SA3. read notes/comments from the supervisor SA4. read and understand the various coding systems as per company norms




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SA5. communicate with departmental and cross functional teams including auditors SA6. listen effectively and be sensitive to cross cultural differences SA7. disclose information only to those who have the right and need to know it SA8. communicate new or changed regulations to relevant members of the

department to initiate any change in processes SA9. use verbal communication etiquette build and maintain good relationships

across functional units and company affiliates


Decision making

The user/individual on the job needs to know and understand how to: SB1. make decisions on a suitable course of action or response SB2. appropriately use the escalation matrix for complex decisions SB3. to make decisions related to mode of communication and involvement of

stakeholders for any co-ordination purpose SB4. manage relationship at work by practicing emotional control and high degree of

interpersonal skills

Plan and Organize

The user/individual on the job needs to know and understand how to: SB5. plan and organize assigned work in order to effectively interact with the various

stakeholders SB6. multi-task and adapt to meet timelines

Analytical thinking

The user/individual on the job needs to know and understand how to: SB7. improve processes by interacting with others and adopting best practices SB8. identify communication delays and address them with appropriate solutions SB9. analyse the various operational steps and resources to make informed decisions

as per SOP SB10. analyse any situation which needs an immediate escalation

Critical Thinking

The user/individual on the job needs to know and understand how to: SB11. critically evaluate his/her actions and words in light to ethical, legal and global

impact

Problem Solving

The user/individual on the job needs to know and understand how to: SB12. spot process disruptions and delays and report and communicate with solutions SB13. discuss any suggestions based on experience

Customer Centricity

The user/individual on the job needs to know and understand how to: SB14. consider impact on human health and drug safety in every activity SB15. liaise effectively and maintain excellent relationship with the internal/external

contacts


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NOS Version Control

NOS Code LFS/N0704







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Annexure

Nomenclature for QP and NOS Qualification Pack

LFS / Q 0101

LFS QP Number (2 numbers)

Q denoting Qualification Pack Occupation (2 numbers)

Occupational Standard

An example of NOS with ‘N’

9 characters

LFS / N 0101

LFS OS Number (2 numbers)

Occupation (2 numbers)

N denoting National Occupational Standard


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The following acronyms/codes have been used in the nomenclature above:

Sub-Sector Range of Occupation Numbers

Pharmaceutical and Biopharmaceutical and Contract Research

01-10

Pharmaceutical 11-20

Biopharmaceutical 21-30

Contract Research 31-50

Sequence Description Example

Three letters Industry name LFS

Slash / /

Next letter Whether QP or NOS Q/N

Next two numbers Occupation code 07

Next two numbers OS number 01


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CRITERIA FOR ASSESSMENT OF TRAINEES

Job Role Pharmacovigilance Associate Qualification Pack LFS/Q0702 Sector Skill Council Life Sciences Sector Skill Development Council

Guidelines for Assessment: 1. Criteria for assessment for each Qualification Pack will be created by the Sector Skill Council. Each Performance Criteria (PC) will be assigned marks proportional to its importance in NOS. SSC will also lay down proportion of marks for Theory and Skills Practical for each PC. 2. The assessment for the theory part will be based on knowledge bank of questions created by the SSC. 3. Assessment will be conducted for all compulsory NOS, and where applicable, on the selected elective/option NOS/set of NOS. 4. Individual assessment agencies will create unique question papers for theory part for each candidate at each examination/training centre (as per assessment criteria below) 5. Individual assessment agencies will create unique evaluations for skill practical for every student at each examination/training centre based on this criteria 6. To pass the Qualification Pack, every trainee should score a minimum of 70% of aggregate marks to successfully clear the assessment. 7. In case of unsuccessful completion, the trainee may seek reassessment on the Qualification Pack.

Compulsory NOS

Total Marks: 400.00 Marks Allocation

Assessment outcomes Assessment Criteria for outcomes Total Mark

Out Of

Theor

y

Skills Practi

cal

Project

Viva

1. LFS/N0701: Perform collection, processing and assessment of Individual Case Study Reports (ICSRs)

Data Collection of ICSR's

100

40 6 15 4 15

PC1. collect data from solicited sources (Patient registries, Interventional and non-interventional studies, post-approval compassionate use programs, name patient programs (Pre-approval) etc.) and unsolicited sources (Regulatory reports, Literature Reports, Spontaneous Reports from healthcare professional/consumer, Internet/digital media etc.,) to strengthen spontaneous reporting of ADRs

PC2. perform literature monitoring of pharmaceutical products by using electronic literature database or offline literature to identify ICSR and other safety related information in compliance with Company’s policies and local Pharmacovigilance requirements for the same


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Compulsory NOS



Out Of

Theor

y

Skills Practi

cal

Project

Viva

PC3. follow-up regularly to obtain additional information relevant to the case as necessary to provide a complete description of the safety event

PC4. handle the calls as required if deputed in drug safety call centres

Processing of ICSR and Triage

35 10 10 5 10

PC5. record the date of receipt for each ADR from initial notification to follow-up communication

PC6. record the date first valid (Day Zero/ Clock start date- considered the day on which the minimum criteria like patient information, suspect drug, AE/ADR, reporter details for a reportable ICSR is fulfilled )

PC7. perform duplicate check of ICSR

PC8. check whether the case is medically confirmed

PC9. ensure that patient’s confidentiality and privacy in accordance with local applicable laws and regulations are adhered to and if necessary, performed by redaction of patient

PC10. perform triage prioritization of 15-day cases

PC11. performing data entry for ICSRs into safety databases and coding of relevant medical terminologies using MedDRA dictionary

PC12. write case narrative in chronological order

PC13. maintain source documents as per Good Pharmacovigilance Practices (GVP)

Reporting Of ICSR

25 5 8 4 8

PC14. interpret all the validated new information from appropriate sources

PC15. perform ICSR reporting by including essential data elements like patient information, reporter details, suspected reaction and suspected medications

PC16. submit expedited reports within given time frame to meet the regulatory reporting timelines

PC17. classify special population cases using pharmaceutical products

Total 100 21 33 13 33

2. LFS/N0702: Use softwares for various

Coding using MedDRA Dictionary, WHO Drug Dictionary and Medical terminologies

100 35 7 12 4 12


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Compulsory NOS



Out Of

Theor

y

Skills Practi

cal

Project

Viva

Pharmacovigilance activities

PC1. use MedDRA software tools

PC2. conduct medical coding of adverse events by using appropriate MedDRA code to ensure accuracy of label AE assessments

PC3. utilize MedDRA coding according to ICH (International Conference on Harmonization) guidelines while coding an adverse event

PC4. deliver outcomes using MedDRA in Clinical trial databases, Investigator’s Brochures, Core Safety Information, Safety summaries, Clinical Study Reports, ICSRs, PSURs and product labelling

PC5. generate line listing and summary tabulation

Study of Drug Safety Databases like Argus, ArisGlobal, Safety Easy (AB Cube)

35 7 12 4 12

PC6. use relevant software tools to support the entry, classification, coding and assessment of adverse event reports, in accordance with international standards and guidelines

PC7. manage reports from all potential sources, including spontaneous, literature and clinical trial safety reports, with extensive support for blinded clinical trials and also to support specific company business processes and SOPs

PC8. facilitate compliance with domestic and global safety reporting obligations for drugs, vaccines, biologics, devices and combination products

PC9. assist in delivering automated global case processing, periodic reporting, E2B intake and submission, comprehensive reporting, detailed analytics and safety operations from within a single system

PC10. assist for specific actions and monitor response timeframes for all key activities such as data entry, assessment, coding and reporting for full compliance

PC11. explain wide range ICSR reports including expedited (serious reports, at risk reports), non-expedited reports and aggregate reports to aid in global adverse event reporting, including the national and other international adverse reporting forms and aggregate report templates

PC12. develop matrix of continuous flow and submission of cases

Working with Pharmacovigilance Databases 30 6 10 4 10


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Compulsory NOS



Out Of

Theor

y

Skills Practi

cal

Project

Viva

PC13. check for software tools’ validation (IQ, OQ & PQ) before using the software tool or databases and perform labelling of ADRs against the approved company labels

PC14. perform manual data entry from ADR paper forms with support from integrated international terminologies (latest versions) such as WHO Drug and MedDRA

PC15. comply with the international ICH E2B standard and support quality review of cases processed and report scheduling

PC16. support the domestic collection and processing of individual case safety report (ICSR) data, and its sharing of reports

PC17. perform post marketing surveillance at the sponsor site, CRO site, hospitals, AMCs (Adverse Drug Reaction Monitoring Centres) to store the safety profile and adverse event reports of the drug

Total 100 20 34 12 34

3. LFS/N0703: Ensure

Regulatory compliance

Compile and review of the regulatory compliance of ICSRs

100

45 10 15 5 15

PC1. ensure timely submission of ICSRs, PSUR, RMP, Signal reports and aggregate reports as per the respective Regulatory Authority submission timeline

PC2. ensure appropriate processes are in place to comply with the respective Regulatory Authority requirement

PC3. review the accuracy of reports on a regular basis to comply with the existing Regulatory requirements and perform the receipt and evaluation of safety data exchange agreements (as applicable)

PC4. ensure that the reports are submitted to regulatory authorities within timelines

Identifying and resolving any issues hampering the regulatory compliance

30 7 10 3 10

PC5. take corrective action in response to non-compliance of reports

PC6. initiate investigate for the deviations

PC7. identify the root cause of the deviation, take corrective and preventive actions and provide adequate trainings. (if required)

PC8. ensure appropriate documentation of these corrective and preventive actions


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Compulsory NOS



Out Of

Theor

y

Skills Practi

cal

Project

Viva

Improving regulatory compliance 25 5 8 4 8

PC9. maintain awareness about current regulatory trends and practices.

PC10. incorporate continuous improvements into Pharmacovigilance processes and policies based on existing Global and Local Regulatory Pharmacovigilance requirements

PC11. participate in regulatory inspection/ internal and client audit

Total 100 22 33 12 33

4. LFS/N0704: Coordinate with relevant internal and external stakeholders

Coordination with internal team members 40 10 15 0 15

PC1. ask queries to the relevant team members to understand the work output requirements

100

PC2. perform a self-run quality check for the cases in coordination with team members, while routing it to the medical reviewer for next workflow

PC3. co-ordinate with various stakeholders in the team for resolution of queries while ensuring the completeness and accuracy of the information entered into the database for all the cases, especially while working on Suspected Unexpected Serious Adverse Reaction or fatal cases for smooth workflow

PC4. inform supervisor on issues requiring intervention

PC5. deliver quality work on time and report any anticipated reasons for delays in the timelines to the concern teams and stakeholders

PC6. seek the information from the supervisor relevant to escalated issues and their solutions

PC7. ensure compliance with company policies and rule

PC8. provide support to Pharmacovigilance scientist/in-charge or supervisor in establishment /upgradation of pharmacovigilance system as and when required related to communication escalations for any co-ordination related activity

Coordination with Cross- Functional Team 40 10 15 0 15

PC9. coordinate with medical affairs team to maintain Medical Information System (MEDINFO)

PC10. impart training to team members/cross-function team members


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Compulsory NOS



Out Of

Theor

y

Skills Practi

cal

Project

Viva

PC11. coordinate with medical review team for a smooth workflow

PC12. support patient support program associate/ data assistant in mining spontaneous reports submitted to national surveillance systems

Respond to audit queries 20 6 7 0 7

PC13. interact with auditor’s in a language he/she is comfortable with

PC14. explain the query clearly and provide response to the auditor

PC15. produce the documented records for activities performed

PC16. maintain data integrity while responding to auditors

Total 100 26 37 0 37

Documents

Contents...permanent organized documented records for all safety reports. The person ensures compliance with local regulations and company`s Global ... PSUR Periodic Safety Update