Meenakashi Jain

Accomplished and conscientious Biotechnology and pharmaceutical professional with proven working experience in Drug Safety, Pharmacovigilance, Regulatory Affairs, Business development and research & development

Employment History
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)
• Bachelor of Science, Dr. Hari Singh Gour University, formerly
University of Sagar, Sagar (India)
• Post Graduate Diploma in Management, Indra Gandhi National
Open University, New Delhi
• Comprehensive Program in Regulatory Affairs for Biologics and
Pharmaceuticals (Indian Biosciences and Research Institute)
Certificates
• C1 (German), Goethe Zentrum