Executive Director, Pharmacovigilance Systems & Enablement

About the role

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Executive Director to join our Global Patient Safety team. The Executive Director, PV Systems & Enablement serves as GPS’ forward-looking pharmacovigilance (PV) domain expert for PV systems and ways of working. This role owns the domain requirements of PV systems, data architecture, PV processes, and AI-enabled capabilities across all of GPS, proactively identifying and proposing modern, innovative, defensible ways of working in a GxP environment.

Responsibilities

• Serve as a domain pharmacovigilance (PV) expert on safety data, process and regulations across all of Global Patient Safety (GPS), proactively identifying and proposing modern, innovative, defensible ways of working in a GxP environment.
• Define and own the PV systems forward looking strategy for GPS, including PV technology systems, data architecture, and AI-enabled capabilities (e.g., agentic AI, Claude, Copilot), partnering with GD-IT and other technology teams on execution
• Define and communicate the function’s vision and strategy in alignment with enterprise goals and business priorities.
• Collaborate with GPS functional leads to align priorities, identify enabling capabilities and develop a single, integrated roadmap that meets patient safety requirements.
• Engage, partner with GD-IT and other technology teams across Regeneron as the PV domain owner, defining requirements, priorities, and dependencies for the GPS roadmap while GD-IT owns technical execution.
• Own and maintain the GPS PV systems roadmap, balancing modernization initiatives with operational sustainability and regulatory compliance.
• Identify opportunities to leverage AI and advanced analytics within PV processes and guide the teams in the appropriate solution design, validation and implementation of those solutions.
• Conduct first-pass domain review and prioritization of AI use cases for GPS, partnering with the enterprise AI Center of Excellence (CoE), which owns formal AI governance.
• Oversee implementation and drive user adoption of AI across GPS, including ongoing compliance and responsible use of AI.
• Ensure new PV systems and ways of working are compliant with all GxP, validation, and data integrity requirements, and are defensible under regulatory inspection.
• Translate business requirements into clear PV systems specifications in partnership with GPS functional leaders, GD IT, and other stakeholders.
• Provide strategic oversight of PV systems (e.g., safety databases, signal detection tools, analytics platforms) to ensure alignment with GPS strategy and operational needs
• Serve as primary GPS liaison with enterprise technology partners (e.g., GD IT, Cloud, Dev Ops, AI CoE, Compliance), representing PV systems and domain requirements.
• Oversee system vendor performance, contract management, and PV systems modernization project delivery
• Build, coach, and scale a high-performing team.
• Lead talent strategy and leadership development initiatives that raise capabilities across the organization.
• Influence cross-functional leaders to align PV priorities and drive enterprise results that benefit GPS and the broader Regeneron organization.

Requirements

• Bachelors Degree (MS preferred)
• 15+ years of experience in pharmacovigilance, safety systems, PV systems modernization, data science, or AI-enabled capabilities within the life sciences industry
• Deep understanding of PV processes and systems, including safety databases, signal detection tools, and reporting platforms.
• Strong knowledge of AI and advanced analytic applications within PV regulated environments.
• Ability to assess, prioritize, and design PV systems and AI-enabled solutions in compliance with global regulatory and quality expectations, in partnership with the enterprise AI CoE and other cross-functional partners.
• Demonstrated experience modernizing PV systems and safety operations, including implementation of AI-enabled or other new PV capabilities in regulated environments.
• Experience leading cross-functional initiatives involving Safety, IT, and data/AI teams.
• Familiarity with AI governance frameworks (partnering with an enterprise AI CoE), validation, and compliance considerations for PV systems in regulated environments.

Work location

Tarrytown, NY, Warren, NJ or Cambridge, MA

4 days per week on site

25% Travel may be required