Executive Director, Pharmacovigilance Systems & Enablement

Regeneron Pharmaceuticals•Cambridge, MA

2d•$255,000 - $424,900•Hybrid

About The Position

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 span PV systems forward looking strategy, first-pass prioritization and domain assessment of AI use cases in partnership with the enterprise AI Center of Excellence (CoE), and partnership with GD-IT and other technology teams to execute the resulting roadmap, while maintaining GxP compliance and day-to-day operational reliability of existing systems. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Requirements

Minimum Bachelors Degree (MS preferred) with 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.

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.