Executive Director, Pharmacovigilance Systems & Enablement Job at Regeneron, Cambridge, MA

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  • Regeneron
  • Cambridge, MA

Job Description

Regeneron seeks an Executive Director to lead pharmacovigilance systems strategy and modernization within Global Patient Safety. This role owns PV domain requirements, data architecture, AI-enabled capabilities, and regulatory compliance across the organization, partnering with IT and enterprise teams.

Responsibilities

  • Define and own PV systems forward-looking strategy, technology roadmap, and AI-enabled capabilities
  • Serve as domain expert identifying modern, innovative, defensible ways of working in GxP environment
  • Partner with GD-IT and technology teams on execution while maintaining operational reliability and compliance
  • Conduct first-pass review and prioritization of AI use cases in partnership with enterprise AI Center of Excellence
  • Build and coach high-performing team while leading talent strategy and leadership development initiatives

Requirements

  • Bachelor's degree minimum; Master's degree preferred in relevant field
  • 15+ years pharmacovigilance, safety systems, PV modernization, or AI experience in life sciences
  • Deep expertise in PV processes, safety databases, signal detection, and reporting platforms
  • Knowledge of AI and advanced analytics in regulated PV environments
  • Demonstrated experience modernizing PV systems and implementing AI capabilities with regulatory compliance
  • Experience leading cross-functional initiatives across Safety, IT, and data/AI teams
  • Familiarity with AI governance frameworks, validation, and compliance for regulated systems

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