Director, Global PV Hub & Safety Operations

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

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