Director, Pharmacovigilance Hub - Americas
About The Position
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director, Pharmacovigilance Hub to join our Global Patient Safety Operations team. The Director, PV Hub oversees country and/or regional level PV execution within their assigned region and ensures that local safety activities are performed in accordance with global standards, local regulatory requirements are met, and all country-generated safety data are accurately and timely integrated into the global PV system. This role serves as the escalation point for local execution issues and as the conduit between local operations and global oversight functions. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Requirements
- 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 the country or regional level
- Ability to coordinate across functions and cultures, operating effectively as an execution and escalation lead rather than a policy owner
- Strong organizational and communication skills, with the ability to surface local risks early and drive resolution through global governance channels
Nice To Haves
- Preferred experience with AI technologies
- Experience working within LATAM, US and Canadian markets strong preferred
Responsibilities
- Maintain a comprehensive understanding of local legislation and Health Authority requirements and keep Worldwide Operations Office (WWOO) leadership informed of updates or changes to local requirements or processes (e.g., SOP addenda, safety communications, labeling updates, and local submission requirements) in alignment with country-specific regulatory requirements
- Track local process status, changes, and risks to drive consistency and continuous improvement for hub’s geographic markets, including maintaining and monitoring via common tool (e.g., tracker, dashboard)
- Develop innovative approaches to delivering on core activities that integrate in new technologies, including AI
- Ensure country compliance with the global PV quality system, supporting inspections, audits, CAPAs, and timely resolution of deviations or non-compliance
- Serve as local safety PoC to coordinate with global GPS (e.g., PV Enablement, CER, SS) and non-GPS (e.g., Med Affairs, Regulatory) teams to: Guide and inform global teams on local requirements and ensure compliance with local legislations
- Coordinate with other PV hub(s) as needed for contributions to activities and/or local documentation
- Shape compliant programs that provide high quality adverse event reports
- Build, coach, and scale a high-performing team, and drive succession planning and talent pipelines
Benefits
- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- fitness centers
- insurance benefits (e.g. medical, dental, vision, life and disability)
- paid time off
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Director
