Job Overview The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of reliable adverse event reports within the context of the product s safety profile as well as other products within the same therapeutic area Also this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products Essential Functions Perform medical review and clarification of trial-related Adverse Events AEs and post-marketing adverse drug reactions ADRs including narrative content queries coding expectedness seriousness causality and company summary Compose edit and medically review Analyses of Similar Events AOSE for expedited cases as appropriate based on regulatory requirements Provide coding review of AEs SAEs SADRs Past medical history Concomitant medications or other medical data listings to verify and medically vet clinical data Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Perform medical safety review of the protocol Investigative Brochure and or Case Report Forms CRFs for appropriate safety content and data capture as applicable Provide aggregate reviews of safety information including but not limited to clinical data postmarketing literature review and observational studies to maintain oversight of a product s safety profile e g DSUR RMP PBRER ad hoc regulatory reports etc Ensure service delivery from productivity compliance and quality perspective within regulatory contracted timelines Lead and participate in the initiatives taken for the same from team delivery pers

📌 Senior Medical Safety Advisor (Bengaluru)
🏢 Iqvia
📍 Bengaluru