Role Overview:
The Drug Safety & Pharmacovigilance (GDS&PV) Physician is a senior medical expert responsible for contributing to the global safety strategy and assessing the safety profile of assigned products throughout their lifecycle. This individual engages cross-functionally within the organization and with external stakeholders, including Regulatory Authorities, to manage safety assessments, review adverse events, and prepare safety reports. The role involves leading safety activities such as signal detection, benefit-risk evaluation, and risk management, ensuring compliance with regulatory standards.
Key Responsibilities:
- Lead pre- and post-marketing safety activities, including signal detection and risk mitigation.
- Collaborate with safety teams on safety assessments, literature reviews, and safety communications.
- Oversee handling of safety issues and implement systemic solutions.
- Prepare safety documentation for regulatory submissions and compliance.
- Manage internal and external safety forums and provide guidance and training on PV principles.
- Engage with stakeholders, including regulatory bodies and external experts, to stay aligned with emerging safety landscapes.
- Mentor and develop junior colleagues to foster growth and expertise.
Qualifications & Skills:
- MD required with 12+ years’ experience in drug safety/pharmacovigilance, preferably in oncology.
- Experience with regulatory submissions, audits, and inspections, including FDA interactions.
- Knowledge of global PV regulations, coding dictionaries, and safety database systems.
- Proven leadership in guiding teams and handling safety-related activities.
This role demands adaptability in a fast-paced environment, strong cross-functional collaboration, and a commitment to advancing patient safety through scientific excellence.