Director, Pharmacovigilance Hub Job at Regeneron Pharmaceuticals, Tarrytown, NY

  • Regeneron Pharmaceuticals
  • Tarrytown, NY

Job Description

Regeneron is seeking a Director, PV Hub to join our Patient Safety organization. In this role the Director oversees country and/or regional level PV execution within their assigned region. The Director ensures 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. The Director serves as an escalation point for local execution issues and as the conduit between local operations and global oversight functions.

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 tools (e.g., tracker, dashboard).
  • Develop innovative approaches to delivering core activities that integrate 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 point of contact 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 hubs 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.
Qualifications
  • 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.
Benefits (U.S.)
  • Health and wellness programs (medical, dental, vision, life, disability insurance)
  • Fitness centers
  • 401(k) company match
  • Family support benefits
  • Equity awards
  • Annual bonuses
  • Paid time off
  • Paid leaves (military and parental leave)

Salary Range (annually): $183,100.00 - $305,200.00.

Regeneron is an equal‑opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.

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Job Tags

Work at office, Local area, Worldwide

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