Director, Global Patient Safety Sciences – General Medicine

Regeneron

. Serve as the first point of contact for all safety-related issues for assigned compounds/assets within a therapeutic area .

Posted 9/21/2026full-timeUnited StatesLead💰 $205,000 - $341,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in pharmacovigilance, including safety strategy development, signal management, and regulatory compliance. Proven ability to lead cross-functional teams and mentor junior professionals while effectively communicating safety findings.

Highest-signal resume keywords

Pharmacovigilance ExperienceSafety Strategy DevelopmentRegulatory ComplianceTeam LeadershipMedical Review Support

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Safety SurveillanceSignal ManagementBenefit-Risk AssessmentDSURs PreparationPSURs PreparationRMP DevelopmentClinical Document ReviewCritical Analysis of FDA GuidelinesPharmacovigilance RegulationsOncology Clinical Experience

Soft Skills

Effective CommunicationCross-Functional CollaborationMentoring

Tools & Technologies

GPS Safety Database

Certifications & Qualifications

PharmDPhDMD

Industry Keywords

Therapeutic AreaClinical DevelopmentSafety Monitoring TeamSOP DevelopmentContinuous Improvement

About the role

Key responsibilities & impact

Serve as the first point of contact for all safety-related issues for assigned compounds/assets within a therapeutic area
Represent Global Patient Safety on cross-functional Strategic Program Teams
Lead safety strategy and ensure optimal support from Global Patient Safety
Direct all Global Patient Safety activities for assigned compounds and products
Support safety surveillance, signal management, safety-profile communication, benefit-risk assessment and regulatory safety responses
Lead preparation and review of DSURs, PSURs, development RMPs, RMPs and clinical documents
Lead cross-functional Safety Monitoring Team activities
Represent Global Patient Safety on RSOC, IDMC, SPT and other internal and external teams
Develop safety strategies and planning for non-compound-specific activities
Provide medical review support for complex ICSRs and other data sources
Participate in developing and maintaining SOPs, working practices and guides
Participate in continuous improvement activities, cultivate cross-functional relationships and mentor junior safety scientists
Serve as a subject matter expert for assigned compounds

Requirements

What you’ll need

Minimum 10+ years of total relevant experience in PV and/or relevant medical field or equivalent industry experience in drug safety, including significant experience with PSURs/DSURs/(d) RMPs; or clinical development with demonstrated achievements in safety
5+ years of total relevant experience in PV and/or relevant medical field with PharmD / PhD / MD degree required
Ability to apply and provide critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities in clinical trial and post-marketing environments
Relevant clinical industry experience in the therapeutic area of interest
Proven ability to lead and develop a diverse team of Safety Professionals
Ability to work across organizational levels and effectively communicate safety viewpoints and findings
Ability to utilize GPS safety database for medical case review and simple queries
Clinical experience and/or industry experience in Oncology 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