Safety Evaluation & Risk Management

Role: Safety Physician (Safety Evaluation & Risk Management)

 Job Responsibilities: Safety Governance and Risk Management activities

2. Contributes to regulatory benefit-risk assessments and prepares the regional Risk Management Plans for designated products In partnership with the product scientist, provides clinical safety input into Clinical Development planning activities

3. Reviews and provides technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters. May present safety information at clinical investigator and commercial meetings. 5. Ensures prompt notification to TA Head of reviewed protocols that are identified as potential PASS Facilitates establishment of Safety Review Teams as necessary, provides data for review and actively contributes to interpretation and discussion.