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 advantage-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.