Pharmacovigilance/Drug Safety
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Accomplished and conscientious Biotechnology and pharmaceutical professional with proven working experience in Drug Safety, Pharmacovigilance, Regulatory Affairs, Business development and research & development
Pharmacovigilance Specialist at ProPharmaGroup, Richmond (UK)
March 2022 — Present
● Manage case assessment, investigation, documentation, medical research, and processing of incoming Adverse Drug Events (ADEs) and
Reactions (ADRs).
● Data entry and quality review of cases from Literature text, Spontaneous,
ICSR, CIOMS and E2Bs in Argus safety database (Triage/Full Data
Entry/Medical narrative & Review comment/Submission) with emphasis on timelines, data accuracy, consistency, and completeness.
● Understanding and working knowledge of MedDra Coding and WHO browsers.
● Contribute towards organizing, planning, and presenting the safety data in line with the template of PSURs.
● Knowledge of relevant FDA, EMA and GVP modules, eCTD, and ICH—GCP guidelines.
● Development of training material.
Business Development Trainee at Garphi Biosciences, Hyderabad (India)
February 2015 — July 2015
● I was engaged in Market analysis of the patented formulations.
● Responsible for strategic Planning and B2B interactions for the new generic drug development.
Research Officer at Natural Remedies Private Limited, Bengaluru (India)
August 2011 — October 2013
● I was engaged in transcribing the results of Research and Development to be utilized for the product promotion.
● Contributed significantly towards the CTD prepa ration for fulfilling the regulatory requirement of different countries
● Organizing, planning, and presenting the safety data in line with the template of PSURs, DSURs.
● Developed SOPs, pack inserts, and labelling artwork for product registration in different countries.
● Prepared the Clinical trial safety report for company product.
Compilation of R&D work for publishing in the peer-reviewed international journals.
Senior Research Fellow at Advance Centre for Treatment Research &
Education in Cancer, Navi Mumbai (India)
May 2008 — March 2011
● Studied the effect of different drugs on cancer cell lines.
● Studied the effect of a drug in Animal model.
● Mentored and supervised master’s students in their dissertation work.
Project Assistant at National Environmental Engineering Research
Institute, Nagpur (India)
June 2006 — April 2008
● Studied the effect of environmental pollutants invitro.
● Supervised Bachelor's and master’s students in dissertation work.
● Presented my work in many conferences (poster and oral presentations)
Adhoc Lecturer at Dr. Hari Singh Gour University, Sagar (India)
December 2005 — May 2006
● Taught bachelor Students Immunology and cell biology.
● Designed experiments for better learning.
Master of Science (Biotechnology), Dr. Hari Singh Gour University,
formerly University of Sagar, Sagar (India)
University of Sagar, Sagar (India)
Open University, New Delhi
Pharmaceuticals (Indian Biosciences and Research Institute)
