Position Summary: The Senior Director of Medical Safety and Pharmacovigilance will lead the medical safety activities for assigned products, ensuring continuous assessment of their safety profiles and benefit-risk balance. This role involves providing strategic leadership in medical safety, supporting clinical development programs, regulatory filings, and global post-marketing safety activities.
Key Responsibilities:
- Oversee the medical assessment and interpretation of safety data from various sources, including clinical trials, post-marketing reports, and literature.
- Lead safety monitoring and signal detection efforts, ensuring timely identification and communication of safety concerns.
- Collaborate with cross-functional teams to support clinical studies, including the development and review of clinical trial protocols, informed consent forms, and safety information.
- Provide medical input for the generation of aggregate safety reports and risk management plans.
- Develop and maintain standard operating procedures and other guidance documents related to drug safety.
- Serve as a subject matter expert for vendors providing pharmacovigilance services.
- Respond to safety-related inquiries from regulatory authorities and participate in regulatory inspections.
- Mentor and manage the Drug Safety team, fostering a collaborative and high-performance environment.
Requirements:
- Medical degree (MD) with at least 8-10+ years of experience in drug safety and pharmacovigilance within the pharmaceutical industry.
- Proven expertise in medical safety assessments, safety surveillance, and risk management.
- Strong knowledge of US and EU pharmacovigilance regulations and guidelines.
- Excellent leadership, organizational, and communication skills.
- Ability to work effectively in a fast-paced, cross-functional environment.
