The ideal candidate should have robust hands-on experience in Signal Detection and Evaluation, Aggregate Report Writing (PSUR/PBRER, Annual Reports), Literature Review, Benefit 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 perk-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 setting is highly preferred.
Thanks & Regards
Babeeta Shahi
📌 Senior Medical Writer Mumbai (India)
🏢 Tata Consultancy Services
📍 India
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