Director, Pharmacovigilance Hub
Regeneron
9 hours ago
On-site
Tarrytown, NY
Operations
In this role, a typical day might include:
- The Director, PV Hub oversees country and/or regional level PV execution within the assigned region.
- Ensures local safety activities align with global standards and meet local regulatory requirements.
- Integrates all country-generated safety data accurately and timely into the global PV system.
- Serves as the escalation point for local execution issues and a conduit between local operations and global oversight.
This role might be for you if you can:
- Maintain knowledge of local legislation and Health Authority requirements; inform WWOO leadership of updates (SOP addenda, safety communications, labeling updates, local submission requirements).
- Track local process status, changes, and risks; maintain and monitor via common tools (e.g., tracker, dashboard) to drive consistency and continuous improvement.
- Develop innovative approaches to core activities, integrating new technologies including AI.
- Ensure country compliance with the global PV quality system, including inspections, audits, CAPAs, and resolution of deviations/non-compliance.
- Act as local safety PoC coordinating with global GPS and non-GPS teams (PV Enablement, CER, SS; Med Affairs, Regulatory) to guide global teams on local requirements and ensure compliance.
- Coordinate with other PV hub(s) as needed for contributions to activities and/or local documentation.
- Shape compliant programs producing high-quality adverse event reports.
- Build, coach, scale a high-performing team, and drive succession planning and talent pipelines.
To be considered, you must have:
- Bachelor’s degree (Advanced degree preferred) with 12+ years 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 as an execution and escalation lead.
- Strong organizational and communication skills; ability to surface local risks early and drive resolution through global governance channels.
Application instructions:
- Apply now.
- The Director, PV Hub oversees country and/or regional level PV execution within the assigned region.
- Ensures local safety activities align with global standards and meet local regulatory requirements.
- Integrates all country-generated safety data accurately and timely into the global PV system.
- Serves as the escalation point for local execution issues and a conduit between local operations and global oversight.
This role might be for you if you can:
- Maintain knowledge of local legislation and Health Authority requirements; inform WWOO leadership of updates (SOP addenda, safety communications, labeling updates, local submission requirements).
- Track local process status, changes, and risks; maintain and monitor via common tools (e.g., tracker, dashboard) to drive consistency and continuous improvement.
- Develop innovative approaches to core activities, integrating new technologies including AI.
- Ensure country compliance with the global PV quality system, including inspections, audits, CAPAs, and resolution of deviations/non-compliance.
- Act as local safety PoC coordinating with global GPS and non-GPS teams (PV Enablement, CER, SS; Med Affairs, Regulatory) to guide global teams on local requirements and ensure compliance.
- Coordinate with other PV hub(s) as needed for contributions to activities and/or local documentation.
- Shape compliant programs producing high-quality adverse event reports.
- Build, coach, scale a high-performing team, and drive succession planning and talent pipelines.
To be considered, you must have:
- Bachelor’s degree (Advanced degree preferred) with 12+ years 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 as an execution and escalation lead.
- Strong organizational and communication skills; ability to surface local risks early and drive resolution through global governance channels.
Application instructions:
- Apply now.