Sameer Shah
Drug Safety Pharmacovigilance Specialist
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About
Pharmacovigilance professional with expertise in adverse drug reaction assessment and causality evaluation. Experienced in analyzing litigation cases and vaccine safety data across multiple countries. Dedicated to contributing to global drug and vaccine safety documentation and Benefits to Risk Analysis. Passionate about preventing pharmaceutical tragedies through meticulous case evaluation and regulatory compliance.
Experience
Drug Safety Pharmacovigilance Specialist - Novartis Pharmaceuticals - Hyderabad
Reading and extracting litigation cases filed by attorneys across US concerning adverse drug reactions. Conducting causality assessment of side-effects and analyzing relationship between adverse events and medicines/vaccines. Contributing to global documentation of Benefits to Risk Analysis.
During
Covid-19 pandemic, performed causality assessment of 500+ Covid-19 vaccination cases from USA, Canada, UK, France, Germany, Brazil, China, India and other countries. Triaged cases involving cardiac injury, myocardial infarction, and neurological complications. Analyzed 14 fatal cases post-vaccination.
Junior Medical Data Analyst - Cognizant Technology Solution
Documented data for oncology drugs including Glivec, Tasigna, Zometa in night shift.
Education
Bachelor of Laws (LLB) - Law - Mumbai University
Bachelor of Homoeopathy Medicine and Surgery - Homoeopathic Medicine - Institute of Homoeopathy
12th Standard - General Studies - Mumbai (School/Board)
