The ideal candidate should have strong 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 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.