Medical Director, Patient Safety Physician

About the role

Medical Director, Patient Safety Physician at AstraZeneca. Safety Strategy and Governance: Own the clinical safety strategy for assigned products across late-stage development and post-marketing.

What you'll do

• Safety Strategy and Governance: Own the clinical safety strategy for assigned products across late-stage development and post-marketing
• Clinical Development Integration: Provide strategic clinical safety input to development planning; give to project-specific safety requirements
• Signal Detection and Evaluation: Lead or give to surveillance activities including medical review of individual cases, signal detection and evaluation
• Labeling and Regulatory Interactions: Provide medical input to labeling updates and responses to regulatory requests
• Regulatory Reports and Submissions: Provide medical input and review of periodic reports (PBRERs, PSURs, DSURs) and renewal documentation

What you need

• 16–29 yrs of experience
• Pharmacovigilance
• Safety management
• Due diligence
• Documentation
• Clinical research
• Litigation
• MBBS