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Regeneron

Senior Director, Global Patient Safety

Regeneron

. Lead assigned-compound safety activities, including surveillance, signal management, safety communication, benefit-risk assessment and regulatory responses .

Posted 10/23/2026full-timeTarrytown • New York • United StatesSenior💰 $242,000 - $403,300 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in pharmacovigilance and drug safety, with a strong focus on risk management, safety communication, and regulatory compliance. Proven ability to lead cross-functional teams and mentor junior staff while influencing decision-making at senior management levels.

Highest-signal resume keywords
Pharmacovigilance ExperienceDrug Safety ReportingRisk ManagementClinical Development ExperienceInfluencing Across Matrix Teams

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
Benefit-Risk AssessmentSafety CommunicationIndividual Case Safety Report ReviewDevelopment Safety Update ReportsPeriodic Safety Update ReportsRisk Management PlansInvestigator Brochure ReviewClinical Study Report ReviewStandard Operating Procedures DevelopmentMechanism-of-Action Planning
Soft Skills
MentoringCollaborationInfluencing
Certifications & Qualifications
Nursing DegreePharmDPhDMD
Industry Keywords
PharmacovigilanceDrug SafetyClinical DevelopmentSafety ManagementRegulatory ResponsesSafety Oversight CommitteeIndependent Data Monitoring CommitteesTherapeutic Area Experience

About the role

Key responsibilities & impact
  • Lead assigned-compound safety activities, including surveillance, signal management, safety communication, benefit-risk assessment and regulatory responses
  • Oversee Development Safety Update Reports, Periodic Safety Update Reports, development Risk Management Plans and Risk Management Plans
  • Review Investigator Brochures, protocols and clinical study reports
  • Chair the Safety Management/Monitoring Team as the first safety contact
  • Coordinate internal support and represent Global Patient Safety cross-functionally
  • Represent safety on the Strategic Program Team, Regeneron’s Safety Oversight Committee, Independent Data Monitoring Committees and partner/contract research organisation teams
  • Deputise for the Therapeutic Area Head
  • Develop non-compound safety strategies, including mechanism-of-action planning
  • Provide complex Individual Case Safety Report medical-review expertise and review other compound data sources
  • Develop standard operating procedures, working practices and guides
  • Mentor junior safety scientists
  • Influence collaboratively across internal and external matrix teams, including senior management

Requirements

What you’ll need
  • Nursing, PharmD, PhD or MD degree
  • Five-plus years’ relevant pharmacovigilance and/or medical experience with a listed degree
  • Ten-plus years’ relevant pharmacovigilance/medical experience, or equivalent in lieu of PharmD/PhD/MD
  • Significant drug-safety reporting and risk-management experience
  • Alternatively, clinical-development experience with demonstrated safety achievements, such as integrated safety summary support or clinical study report content responsibility
  • Ability to influence colleagues across matrix teams, including senior management
  • Clinical and/or industry experience in the relevant therapeutic area is a plus

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