Patient Safety Sr. Medical Director, Global PV/ Patient Safety Medical Operations Excellence
About The Position
Supervise medical reviews for ICSRs during both clinical development and post-marketing, managing workflows and oversight to ensure evaluations are timely, accurate, and compliant. Serve as the main contact between operations and global patient safety medical teams. This position will contribute to setting standards, enhancing quality and inspection preparedness, executing vendor management, and working with both internal and external stakeholders to share medical expertise with operations teams and communicate operational regulatory requirements to the medical and PV Science groups.
Requirements
- MD or DO Required; board certification preferred.
- 10+ years in Pharmacovigilance, 5+ in global medical review management.
- Strong knowledge of PV regulations, inspection, and audit processes.
- Proficient with Argus Safety Database and vendor management/oversight.
- Experience integrating medical review of ICSRs into signal detection and management.
- Expert clinical judgment and narrative writing.
- Deep regulatory and compliance expertise.
- Proven operational leadership and change management.
- Systems/data skills, especially Argus and E2B(R3).
- Effective communicator and cross-functional collaborator.
Responsibilities
- Lead the operational strategy and standards for ICSR medical review across all case types.
- Conduct thorough clinical evaluations, handling complex cases and support prioritization of the medical review workflow.
- Connect ICSR reviews to benefit–risk assessment, informing signal detection and management activities.
- Ensure compliance with global regulations and internal procedures; lead QA/QC improvements and enhance inspection preparedness in collaboration with PV Compliance and ICSR Teams.
- Refine and monitor KPIs/SLAs for medical review timeliness, accuracy, and consistency; drive process enhancements and support automation efforts with both internal and vendor staff.
- Oversee vendor performance and harmonize medical review training and processes for internal/external teams.
- Collaborate cross-functionally within GPS to ensure medical insights inform safety reports and risk management plans.
- Maintain governance documentation and deliver metrics and analyses to leadership.
Benefits
- medical
- dental
- vision benefits
- paid time off (including a week-long company shutdown in the Summer and the Winter)
- educational assistance programs including student loan repayment
- a generous commuting subsidy
- matching charitable donations
- 401(k)
- annual bonus
- annual equity awards
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
1,001-5,000 employees
