Director, Pharmacovigilance Hub
Regeneron
August 10, 2026
Remote friendly (Tarrytown, NY)
United States
Operations
Director, Pharmacovigilance Hub (Global Patient Safety Operations)
Responsibilities:
- Maintain knowledge of local legislation and Health Authority requirements; keep WWOO leadership informed of updates/changes to requirements or processes (e.g., SOP addenda, safety communications, labeling, local submissions).
- Track local process status, changes, and risks to drive consistency and continuous improvement; maintain/monitor via common tools (e.g., tracker, dashboard).
- Develop innovative approaches to core activities integrating new technologies, including AI.
- Ensure country compliance with the global PV quality system; support inspections, audits, CAPAs, and timely resolution of deviations/non-compliance.
- Serve as local safety point of contact to coordinate with global and non-global teams:
- Guide and inform global teams on local requirements and ensure compliance with local legislations.
- Coordinate with other PV hub(s) as needed for contributions and/or local documentation.
- Shape compliant programs that produce high-quality adverse event reports.
- Build, coach, and scale a high-performing team; drive succession planning and talent pipelines.
Qualifications:
- Minimum Bachelor’s Degree (Advanced Degree preferred) with 12+ years of PV experience and demonstrated achievements in patient safety.
- Experience supporting regulatory inspections, audits, and quality issue management at country/regional level.
- Preferred experience with AI technologies.
- Ability to coordinate across functions and cultures; act as execution and escalation lead rather than a policy owner.
- Strong organizational and communication skills; ability to surface local risks early and drive resolution through global governance channels.
Application Instructions:
- Apply now.
Responsibilities:
- Maintain knowledge of local legislation and Health Authority requirements; keep WWOO leadership informed of updates/changes to requirements or processes (e.g., SOP addenda, safety communications, labeling, local submissions).
- Track local process status, changes, and risks to drive consistency and continuous improvement; maintain/monitor via common tools (e.g., tracker, dashboard).
- Develop innovative approaches to core activities integrating new technologies, including AI.
- Ensure country compliance with the global PV quality system; support inspections, audits, CAPAs, and timely resolution of deviations/non-compliance.
- Serve as local safety point of contact to coordinate with global and non-global teams:
- Guide and inform global teams on local requirements and ensure compliance with local legislations.
- Coordinate with other PV hub(s) as needed for contributions and/or local documentation.
- Shape compliant programs that produce high-quality adverse event reports.
- Build, coach, and scale a high-performing team; drive succession planning and talent pipelines.
Qualifications:
- Minimum Bachelor’s Degree (Advanced Degree preferred) with 12+ years of PV experience and demonstrated achievements in patient safety.
- Experience supporting regulatory inspections, audits, and quality issue management at country/regional level.
- Preferred experience with AI technologies.
- Ability to coordinate across functions and cultures; act as execution and escalation lead rather than a policy owner.
- Strong organizational and communication skills; ability to surface local risks early and drive resolution through global governance channels.
Application Instructions:
- Apply now.