Director, Pharmacovigilance Hub - Americas

Regeneron Pharmaceuticals, Inc.; Kentucky; On-site; USD 183,000 - 305,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Director, Pharmacovigilance Hub to lead local PV execution within Global Patient Safety Operations.

The role ensures local safety activities meet global standards and regulatory requirements, and that country safety data are integrated into the global PV system. Based at work locations including Tarrytown, NY, Cambridge MA, or Warren, NJ, this on-site role drives cross-functional collaboration, drives risk management, and builds a high-performing team to

Qualifications

• 12+ years of pharmacovigilance experience with patient safety focus.
• Experience supporting regulatory inspections, audits, and quality issue management at country/region level.
• Preferred experience with AI technologies.

Responsibilities

• Maintain a comprehensive understanding of local legislation and health authority requirements and inform WWOO leadership of updates.
• Track local process status, changes, and risks to drive hub consistency and improvement.
• Develop innovative approaches to core activities, integrating new technologies including AI.
• Ensure country compliance with the global PV quality system and support inspections, audits, CAPAs, and deviations resolution.
• Serve as local safety point of contact coordinating with global GPS and non-GPS teams to align local requirements and documentation.
• Build, coach, and scale a high-performing PV team and plan for succession.

Skills

PV experience

Regulatory inspections

AI technologies (preferred)

Education

Bachelor's degree in life sciences

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.

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:

• MinimumBachelor’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.

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 experience. In 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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

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.

Salary Range (annually) $183,100.00 - $305,200.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.