PV Systems & AI Enablement Director

Regeneron Pharmaceuticals, Inc; Village of Tarrytown (NY); On-site; USD 255,000 - 425,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks an Executive Director to lead Global Patient Safety PV systems and enablement. You will own PV systems strategy, data architecture, and AI-enabled capabilities, partnering with IT and the AI CoE to drive a forward-looking roadmap while ensuring GxP compliance.

The role emphasizes building a high-performing team, guiding AI governance, and delivering modernization initiatives across GPS with strong regulatory alignment and data integrity.

Qualifications

• Bachelor's degree required; MS preferred, with 15+ years in pharmacovigilance or PV systems.
• Deep understanding of PV processes, safety databases, signal detection tools, and reporting platforms.
• Experience with AI-enabled capabilities in regulated life sciences environments.
• Proven ability to lead cross-functional initiatives across Safety, IT, and data/AI teams.
• Familiarity with AI governance and validation/compliance considerations for PV systems.

Responsibilities

• Serve as a PV domain expert on safety data, processes and regulations across GPS.
• Define and own GPS PV systems forward looking strategy including technology, data architecture, and AI-enabled capabilities.
• Define and communicate the function's vision aligned with enterprise goals.
• Collaborate with GPS leads to align priorities and develop a unified roadmap.
• Engage with GD-IT and other technology teams on execution.
• Maintain GPS PV systems roadmap balancing modernization and regulatory compliance.
• Identify opportunities to leverage AI and advanced analytics within PV processes.
• Oversee AI adoption across GPS with compliance and responsible use.
• Ensure PV systems are compliant with GxP, validation and data integrity.
• Translate business requirements into PV systems specifications.
• Provide strategic oversight of PV systems like safety databases, signal tools, analytics platforms.
• Lead vendor management and project delivery.
• Build and scale a high-performing team.
• Lead talent strategy and leadership development.

Skills

PV systems

Data architecture

AI-enabled capabilities

GxP compliance

Cross-functional leadership

Education

Bachelor's degree

MS preferred

Tools

Safety databases

Signal detection tools

Analytics platforms

AI governance frameworks

Job description

Regeneron Pharmaceuticals, Inc. seeks an Executive Director to lead Global Patient Safety PV systems and enablement. You will own PV systems strategy, data architecture, and AI-enabled capabilities, partnering with IT and the AI CoE to drive a forward-looking roadmap while ensuring GxP compliance.

The role emphasizes building a high-performing team, guiding AI governance, and delivering modernization initiatives across GPS with strong regulatory alignment and data integrity.