Pooja Verma, PhD
Pharmacovigilance and Regulatory Specialist
Gurgaon
Summary
A Regulatory and Pharmacovigilance Specialist is a professional responsible for ensuring that pharmaceutical products meet regulatory requirements and maintain patient safety throughout their lifecycle. This role combines regulatory affairs and pharmacovigilance to guarantee compliance with health authorities' regulations and to monitor the safety of drugs once they are in the market.
Overview
8
8
years of professional experience
4
4
Languages
Work History
Sr. Safety and Regulatory Specialist-Trainer Role
Syneos Health.
04.2023 - Current
- Giving Training to new associates and refreshers and updates to the existing associates on the manuals applicable for case processing and regulatory updates.
- Leading team for Regulatory Reporting- Ensure the timely submission of safety reports to regulatory authorities (e.g., FDA, EMA), PMDA) in compliance with local and international regulations.
- Investigating the issues raised by the client in terms of case processing, late reporting to the regulatory bodies.
- Ensure that team members understand regulatory submissions, safety reporting, and adherence to regulatory standards.
- Experienced in PMDA and investigator submission in Japan.
- Stay informed about global regulatory requirements and trends that may impact drug approval and market access.
- Managing, writing and investigating CAPA’s and taking care of issue logs.
Safety Specialist Level I & II
Syneos Health
07.2019 - 03.2023
- Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD).
- Performing Follow up activities by sending follow up packs to HCP in response to the queries requested by medical physicians.
Regulatory Affair Executive
Clini Expert
06.2017 - 09.2017
- Sugam Portal Submissions: Utilized the Portal for the submission of regulatory applications related to cosmetics ensuring full compliance with CDSCO guidelines.
- Product Registration & Renewal: Managed the online registration, renewal, and modification processes for cosmetics and pharmaceutical products.
Assistant Lecturer
GD Goenka University
09.2017 - 05.2019
- Teaching and coordination of Pharmacology and human anatomy and physiology in undergraduate medical students of pharmacy, Physiotherapy and Medical lab technology; curriculum design, development and review.
- Head coordinator of Enterprise resource planning software(ERP).
Education
B.Pharmacy -
Jamia Hamdard University
New Delhi, India 04.2001 -
M.Pharmacy - Pharmacology
Jamia Hamdard University
New Delhi, India 04.2001 -
Ph.D. - Pharmacology
GD Goenka
New Delhi, India 04.2001 -
Senior Secondary -
Navyug School
New Delhi, India 04.2001 -
Higher Secondary - Medical
Navyug School
New Delhi, India 01.2010 - 01.2011
Skills
Regulatory Knowledge and Expertise
Regulatory submissions
Communication Skills
Analytical and Critical Thinking
Regulatory Intelligence and Market Awareness
Additional Skills
- Experienced Regulatory Affairs Specialist with a thorough understanding of the NDCT (New Drug and Clinical Trial) Rules, 2019.
- Well Versed with guidelines (e.g., ICH, USFDA, EMA, ASEAN CTD) to ensure compliance.
- Experienced Regulatory Affairs Specialist with a deep understanding of medical device regulatory requirements and hands-on experience navigating global regulatory frameworks.
- Well versed with policies- Orphan drug policies, OTC drug policies
Accomplishments
GPAT Qualified- Qualified graduate aptitude test in 2015.
Gold Medalist- Awarded gold medal by IPA(Indian pharmaceutical association(IPA) in year 2014 for top scoring among pharmacy colleges in Delhi
Timeline
Sr. Safety and Regulatory Specialist-Trainer Role
Syneos Health.
04.2023 - Current
Safety Specialist Level I & II
Syneos Health
07.2019 - 03.2023
Assistant Lecturer
GD Goenka University
09.2017 - 05.2019
Regulatory Affair Executive
Clini Expert
06.2017 - 09.2017
Higher Secondary - Medical
Navyug School
01.2010 - 01.2011
B.Pharmacy -
Jamia Hamdard University
04.2001 -
M.Pharmacy - Pharmacology
Jamia Hamdard University
04.2001 -
Ph.D. - Pharmacology
GD Goenka
04.2001 -
Senior Secondary -
Navyug School
04.2001 -
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