Director, Pharmacovigilance Hub - Americas

Regeneron Pharmaceuticals; New Jersey; On-site; USD 183,000 - 305,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension/retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, V

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals is seeking a Director, Pharmacovigilance Hub to lead Global Patient Safety Operations. You will ensure local PV activities meet global standards, regulatory requirements, and integrate data into the global PV system.

Location options include Tarrytown NY, Cambridge MA, or Warren NJ with four days on site. Lead a high-performing team and drive improvements across LATAM, US, and Canada regions.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 12+ years of PV experience and demonstrated patient safety achievements.
• Experience supporting regulatory inspections, audits and quality issue management.

Responsibilities

• Maintain understanding of local legislation and health authority requirements for PV.
• Track local process status and risks to drive hub consistency across markets.
• Coordinate with global GPS and local teams to ensure compliance and high-quality AE reports.
• Build and lead a high-performing PV hub team and plan succession.

Education

Bachelor’s Degree

Advanced Degree preferred

Tools

AI technologies

Job description

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 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

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.

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
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . 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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site 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)

$183,100.00 - $305,200.00