Perform medical review of clinical trial and post‑marketing AEs/SAEs/ADRs, including narratives, causality, seriousness, expectedness, coding, and queries.
Provide medical oversight for safety surveillance activities for assigned products.
Prepare, review, and contribute to aggregate safety reports (e.g., DSURs, PBRERs, RMPs, ad‑hoc regulatory reports).
Author and medically review analyses of similar events (AOSE) and support signal detection activities.
Review protocols, Investigator Brochures, and CRFs for safety content and data capture.
Serve as a medical expert and internal consultant to pharmacovigilance, RWE, and project teams.
Represent medical safety findings in project and client meetings; support audits and inspections.
Act as Lead Safety Physician or senior backup on assigned projects, including escalation support when required.
Mentor junior medical and safety team members and support training, transitions, and knowledge sharing.
Ensure quality, compliance, and timely delivery of medical safety services.
Maintain awareness of evolving pharmacovigilance and regulatory requirements.
