The ideal candidate should have robust hands-on experience in Signal Detection and Evaluation, Aggregate Report Writing (PSUR/PBRER, Annual Reports), Literature Review, Perk Risk Assessment, Regulatory Safety Reporting, Clinical Study Safety Activities etc.
Candidates should be comfortable participating in or presenting at Safety Review Teams (SRTs) and collaborating with cross-functional stakeholders on benefit-risk assessments, risk management plans, labeling updates, and safety governance activities. Experience in reviewing and interpreting safety data, supporting regulatory submissions, and working in a global pharmacovigilance workplace is highly preferred.
Thanks & Regards
Babeeta Shahi
📌 Senior Medical Writer Mumbai (India)
🏢 Tata Consultancy Services
📍 India
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