Director, Pharmacovigilance Hub - Americas
Regeneron Pharmaceuticals
Summary
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.
Job description
When & where
- Work Location: Tarrytown, NY, Cambridge MA or Warren, NJ
- 4 days per week on site
Discover your role
- 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
This role requires
- 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
- Preferred experience with AI technologies
- 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
- Experience working within LATAM, US and Canadian markets strong preferred
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
- Preferred experience with AI technologies
- 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
- Experience working within LATAM, US and Canadian markets strong preferred
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.