Curriculum Vitae

Kumar Sambhav

Email: sambhav47@gmail.com ~ Contact no: +918591767752

Career Objective:

Seeking the position of a Safety Specialist and looking forward to a job or assignment that will be

professionally challenging; contributing to it by utilizing my knowledge, potential, and positive mindset to

the best of my ability and work with sincerity and diligence in the best possible manner for the benefit of the

organization.

Professional Experience:

1. Organization: Quintiles

Duration: September 2014 – till date

Job Title: Associate Operations Specialist

Summary: Review, assess and process safety data received from various sources and distribute reports/data

onwards to Client/ Regulatory Authorities.

Key Roles and Responsibilities:

Receive, triage, review and process SAE and /Adverse event reports from various sources on time and quality standards.

Writing narratives: Create complete, accurate and succinct narratives (Serious and Non-serious) adhering to established processes.

MedDRA (Medical Dictionary for Drug Regulatory Activities) for Event Coding.

Ensuring reports are sent to client (submission in the client database) within agreed timelines; updating narratives when updated information is received, as appropriate; liaising with client, executing case closure, and reconciliation.

Identifying SAEs and AEs from literature sources and processing them appropriately.

Identifying suspect product following receipt of report; identifying reporting sources; and assessing reportability and expectedness of events.

Prioritize cases according to regulatory and project/client requirements.

Identify and record quality problems and bring them to the attention of Senior Team Members and Line Managers. Do a root cause of errors and understand the corrections required for cases not accurately data based.

Review and respond to e-mails after discussion with mentors/as appropriate and attend all appropriate meetings (Quintiles and/ client).

Complete all trackers applicable in the process.

Code time appropriately and apply leaves after discussion with Line Managers.

Attend and/ complete all trainings (Quintiles and client) within the specified timeline.

Ensure integrity and completeness of data according to applicable regulations and guidelines, SOPs and project-specific guidelines.

Mentor less experienced/new staff members.

Well versed with working of ARGUS safety database.

Academics:

Last Date Attended

Institution Name, Country

Education Level/Degree

Area of Study Percentage

06/2014 National Institute of Pharmaceutical Education and Research, India

M.S (Pharm) Pharmacology and Toxicology

8.92/10 CGPA

08/2011 T. John College of Pharmacy, India

B. Pharm Pharmaceutical Sciences

76.51%

Workshops Attended:

3rd Bangalore Nano - Frontiers of Nanotechnology - 2010.

62nd Indian Pharmaceutical Congress-2010, Manipal University.

Continued Medical Education-2010 Clinical Pharmacology, PMCH - Patna.

Poster presentation - “Evaluation of efficacy of nanocrystalline solid dispersion formulation of hesperetin in diabetic complications”, during 11th Annual Conference of International Society for Heart Research (Indian Section), held at NIPER, Mohali.

M.S. (PHARM) Project:

Evaluation of pharmacological effects of nanocrystalline solid dispersion formulation of hesperetin in diabetic cardiomyopathy - In this project, we employed the technology of Nanocrystalline solid dispersion (NSD) which has emerged as a viable alternative delivery platform for poorly water-soluble drugs like hesperetin (HRN), classified under Biopharmaceutics Classification System (BCS) class-II. In this, the active pharmaceutical ingredient (API) is present as a bunch of nanocrystalline particles in a matrix of excipients (developed by Prof. Arvind Bansal, Department of Pharmaceutics, NIPER, Mohali). In the current study, nanocrystalline solid dispersion (NSD) formulation of hesperetin (HRN) was investigated in diabetes induced cardiomyopathy. Streptozotocin (55 mg/kg) i.p. single dose was used to induce diabetes in male Sprague Dawley (SD) rats. After six weeks of diabetes, rats were treated with NSD and HRN at 30 and 100 mg/kg body weight orally for two weeks. Cardiac functions such as heart rate (HR), left ventricular systolic pressure (LVSP), left ventricular end

diastolic pressure (LVEDP), rate of rise (+dP/dt) and rate of fall (-dP/dt) of left ventricular pressure were measured using Powerlab Instrument. Vascular parameters such as SBP (Systolic Blood Pressure) and DBP (Diastolic Blood Pressure) were also measured. Cardiac fibrosis was quantified on Sirius red-stained sections with Image pro Plus software. Cardiac structural derangements were examined by morphological examination with hematoxylin and eosin staining.

Publication:

1. Emerging Potential of Citrus Flavanones as an Antioxidant in Diabetes and its Complications, Citation: Current Topics in Medicinal Chemistry, December 2014, 1873-4294 Author(s): Sharma M, Akhtar N, Sambhav K, Shete G, Bansal AK, Sharma SS. Publication type: JOURNAL ARTICLE Molecular Neuropharmacology Laboratory, Department of Pharmacology and Toxicology, NIPER Mohali, Punjab, India.

Core Competencies:

Excellent exposure in handling safety database ARGUS

Knowledge of Regulations and Guidelines with respect to Pharmacovigilance (ICH GCP Guidelines, ICMR

Guidelines)

Knowledge of MedDRA and WHO DD coding

Qc reviewer: Review data entered in safety database for completeness and accuracy

Narrative Writer : Responsible for writing medically relevant safety narrative of cases and checking the

completeness and accuracy of the data entered in the various fields

Scientific Data Retrieval – Pubmed, Science Direct, Google Scholar, Spingerlink and SciHub

Awards and achievements:

Qualified NIPER-JEE (2012), an entrance examination conducted by National Institute of Pharmaceutical

Education and Research (NIPER) with AIR – 58.

Qualified Graduate Pharmacy Aptitude Test (GPAT), 2012 organised by Maharaja Sayajirao University,

Vadodara with AIR – 633.

Awarded 1st prize in Quizzophrenia (Quiz Competition) held at NIPER, 2013.

Won many prizes in Cricket Tournaments at school and college level.

Awarded with Applause! award for Quality at Quintiles.

Awarded with Bravo! award for Customer Service at Quintiles.

Personal Attributes and Skill Set:

Taking initiative and completing projects within timelines

Highly motivated and diligent

Punctual and inquisitive

Team Player and Leadership Skills

Flexible and Enthusiastic

Adaptive to condition

Work efficiently under pressure

Analytical and problem solving ability

Languages: Fluent English, Fluent Hindi

Personal Details:

Name: Kumar Sambhav

Sex: Male

Date of Birth: 20th August, 1987

Marital Status: Unmarried

Father’s Name: Dr. Anil Kumar

Mother’s Name: Mrs. Manimala

Permanent Address: Flat no. 27/5, L.F.1, road no. 10E, Rajendra Nagar, Patna-800016, Bihar, India

Declaration:

I hereby solemnly declare that all the information furnished by me is true to best of my knowledge and belief. If given a chance, I will prove myself as an asset to your organization.

PLACE: KUMAR SAMBHAV