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Job description
About the Role
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
Work Location: Tarrytown, NY, Cambridge MA or Warren, NJ 4 days per week on site
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
Requirements
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
Additional Details
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.
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.
In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience.
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
Salary Range (annually) $183,100.00 - $305,200.00
For additional information about Regeneron benefits in the U.S., please visit For other locations, additional information will be provided during the recruitment process.
About Regeneron
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.
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Worksite address
cambridge, MA, 02140, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.