Director, Medical Safety

**Responsibilities**

+ Conduct medical review of clinical trial and post-marketing safety data, including adverse events (AEs), adverse drug reactions (ADRs), coding, causality, expectedness, seriousness assessments, and benefit-risk evaluations.
+ Provide medical oversight and review of safety documentation, including narratives, aggregate reports, annual and periodic safety reports, risk management plans, regulatory submissions, labeling, protocols, investigator brochures, and case report forms.
+ Support safety governance activities, including Data Safety Monitoring Boards, Safety Monitoring Committees, medical information escalations, pharmacovigilance oversight, and 24-hour medical support as required.
+ Serve as Global Safety Physician, project lead, or medical safety advisor, ensuring quality, compliance, operational delivery, training, stakeholder communication, and timely completion of deliverables.
+ Present safety findings and provide expert medical cons...