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Regeneron

Executive Director, Pharmacovigilance Systems – Enablement

Regeneron

. Serve as a domain pharmacovigilance expert on safety data, processes, and regulations across Global Patient Safety .

Posted 9/21/2026full-timeUnited StatesLead💰 $255,000 - $424,900 per yearWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Expertise in pharmacovigilance processes and systems, with a strong focus on AI-enabled capabilities and regulatory compliance. Proven ability to lead cross-functional initiatives and modernize PV systems while ensuring data integrity and operational sustainability.

Highest-signal resume keywords
Pharmacovigilance ExpertiseAI-Enabled Solutions DesignSafety Database ManagementCross-Functional LeadershipRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
PharmacovigilanceSafety Systems ModernizationData ScienceAI ApplicationsSignal Detection ToolsSafety DatabasesPV Systems SpecificationsAdvanced AnalyticsGxP ComplianceValidation Requirements
Soft Skills
Team BuildingLeadership DevelopmentInfluencing SkillsCollaborationStrategic Communication
Tools & Technologies
Analytics PlatformsAI Governance FrameworksSafety Reporting PlatformsPV SystemsContract Management Tools
Industry Keywords
Life SciencesGlobal Patient SafetyRegulated EnvironmentsOperational SustainabilityData Integrity

About the role

Key responsibilities & impact
  • Serve as a domain pharmacovigilance expert on safety data, processes, and regulations across Global Patient Safety
  • Define and own the PV systems forward-looking strategy, including technology systems, data architecture, and AI-enabled capabilities
  • Partner with GD-IT and other technology teams on roadmap execution
  • Define and communicate the function’s vision and strategy in alignment with enterprise goals
  • Collaborate with GPS functional leads to develop an integrated roadmap
  • Define requirements, priorities, and dependencies for the GPS roadmap as PV domain owner
  • Maintain the GPS PV systems roadmap while balancing modernization, operational sustainability, and regulatory compliance
  • Identify opportunities for AI and advanced analytics in PV processes and guide solution design, validation, and implementation
  • Conduct first-pass review and prioritization of AI use cases for GPS with the enterprise AI Center of Excellence
  • Oversee AI implementation, user adoption, compliance, and responsible use across GPS
  • Ensure PV systems and ways of working meet GxP, validation, and data integrity requirements
  • Translate business requirements into PV systems specifications
  • Provide strategic oversight of safety databases, signal detection tools, and analytics platforms
  • Serve as primary GPS liaison with enterprise technology partners
  • Oversee system vendor performance, contract management, and PV systems modernization delivery
  • Build, coach, and scale a high-performing team
  • Lead talent strategy and leadership development initiatives
  • Influence cross-functional leaders to align PV priorities and drive enterprise results

Requirements

What you’ll need
  • Minimum 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
  • 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, validation, and compliance considerations for PV systems in regulated environments
  • 25% travel may be required

Benefits

Comp & perks
  • Annual bonuses or other incentive plans
  • Equity awards
  • Pension or retirement benefits
  • 401(k) company match
  • Health and wellness programs
  • Fitness centers
  • Medical, dental, vision, life and disability insurance benefits
  • Paid time off
  • Family support benefits
  • Reasonable accommodation during the recruitment process where required