Director, Pharmacovigilance Hub Americas

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.

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 hubs 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:

• MinimumBachelors 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

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion or belief (or lack thereof) sex sexual orientation gender identity or expression gender reassignment marital or civil partnership status civil status pregnancy or parental status age disability nationality citizenship status ethnic or national origin membership of the Traveler community familial status genetic information military or veteran status or any other characteristic protected under applicable law. Where required we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process unless such accommodation would impose undue hardship.

Where necessary we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment specific role level and your skills and some countries collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include depending on country and role: 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 and family support benefits. For additional information about Regeneron benefits in the U.S. please visit For other locations additional information will be provided during the recruitment process. If you have any questions please speak with your recruiter.

Please be advised that at Regeneron we believe we do our best work when we are together. For that reason many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

Required Experience:

Director