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Regeneron

Director, Pharmacovigilance Hub – Americas

Regeneron

. Oversee country- and/or regional-level pharmacovigilance execution within the assigned region .

Posted 9/30/2026full-timeUnited StatesLead💰 $183,100 - $305,200 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates extensive expertise in pharmacovigilance execution, ensuring compliance with local and global safety standards while effectively coordinating across functions and cultures. Proven ability to lead high-performing teams and manage regulatory inspections and audits within the pharmaceutical industry.

Highest-signal resume keywords
Pharmacovigilance ExperienceRegulatory CompliancePatient Safety ManagementAI TechnologiesTeam Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Pharmacovigilance ExecutionRegulatory InspectionsQuality Issue ManagementAdverse Event ReportingData IntegrationRisk TrackingProcess ImprovementCompliance MonitoringSafety Data AnalysisInnovative Technology Implementation
Soft Skills
Organizational SkillsCommunication SkillsCross-Functional CoordinationCultural SensitivityCoaching and Mentoring
Tools & Technologies
TrackersDashboardsGlobal PV SystemsAI Technologies
Certifications & Qualifications
Bachelor’s DegreeAdvanced Degree (Preferred)
Industry Keywords
Pharmaceutical IndustryLATAM MarketUS MarketCanadian MarketHealth Authority Requirements

About the role

Key responsibilities & impact
  • Oversee country- and/or regional-level pharmacovigilance execution within the assigned region
  • Ensure local safety activities follow global standards and local regulatory requirements
  • Ensure country-generated safety data are accurately and timely integrated into the global PV system
  • Serve as the escalation point for local execution issues and conduit between local operations and global oversight functions
  • Maintain understanding of local legislation and Health Authority requirements
  • Inform WWOO leadership of local requirement or process updates
  • Track local process status, changes, and risks using common tools such as trackers or dashboards
  • Develop innovative approaches incorporating new technologies, including AI
  • Ensure country compliance with the global PV quality system
  • Support inspections, audits, CAPAs, and resolution of deviations or non-compliance
  • Coordinate with global GPS, non-GPS, and other PV hub teams
  • Guide global teams on local requirements and compliance
  • Shape compliant programs that provide high-quality adverse event reports
  • Build, coach, and scale a high-performing team
  • Drive succession planning and talent pipelines

Requirements

What you’ll need
  • Minimum Bachelor’s Degree (Advanced Degree preferred)
  • 12+ years of pharmacovigilance experience
  • Demonstrated achievements in patient safety
  • Experience supporting regulatory inspections, audits, and quality issue management at the country or regional level
  • Preferred experience with AI technologies
  • Ability to coordinate across functions and cultures
  • Strong organizational and communication skills
  • Experience working within LATAM, US, and Canadian markets strongly preferred
  • Must comply with local regulatory requirements and global PV quality standards

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