Role Overview: The Drug Safety & Pharmacovigilance (GDS&PV) Physician contributes to the global safety strategy and overall safety profile of assigned products throughout their lifecycle. As a Director-level individual contributor, you will collaborate cross-functionally and externally with regulatory authorities, managing safety assessments, reviewing adverse events and scientific literature, and preparing safety reports. The role involves leading safety activities, overseeing risk mitigation, and providing guidance and training on PV principles.
Key Responsibilities:
- Lead safety-related activities, including signal detection, benefit-risk evaluation, and risk management.
- Collaborate with safety and cross-functional teams on safety assessments, surveillance, and communication.
- Oversee handling of safety issues, risk mitigation strategies, and systemic solutions.
- Prepare regulatory documentation, safety summaries, and clinical trial reports.
- Manage forums with external and internal stakeholders, including Data Monitoring Committees and Safety Committees.
- Provide guidance, training, and mentorship on PV processes, regulations, and emerging safety aspects.
- Engage proactively with regulatory authorities and internal project teams.
Qualifications & Skills:
This role is essential for ensuring product safety, regulatory compliance, and supporting the development of innovative therapies to improve patient outcomes.