Director, Medical Safety

Employment type: Full time; Home-based. Requisition: R1558654.

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 consultation to clients, internal teams, and cross-functional stakeholders. - Lead and develop medical safety teams through people management, workload planning, performance management, mentoring, training, resource allocation, and succession planning1 …