Senior Director, Global Patient Safety – Rare Disease

Regeneron

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

Posted 10/30/2026full-timeUnited StatesSenior💰 $242,000 - $403,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in pharmacovigilance, safety strategy development, and regulatory compliance, with a strong background in clinical document review and cross-functional team leadership. Proven ability to mentor safety professionals and communicate effectively across organizational levels.

Highest-signal resume keywords

Pharmacovigilance ExperienceSafety Strategy DevelopmentClinical Document ReviewRegulatory ComplianceTeam Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceSafety SurveillanceSignal ManagementBenefit-Risk AssessmentPSURsDSURsRMPsClinical DevelopmentData AnalysisMedical Case Review

Soft Skills

Effective CommunicationMentoringCross-Functional CollaborationCritical AnalysisRelationship Building

Tools & Technologies

GPS Safety Database

Certifications & Qualifications

PharmDPhDMD

Industry Keywords

Drug SafetyTherapeutic AreaFDA GuidelinesEU RegulationsICH GuidelinesAdvanced TherapiesGene TherapySafety Management TeamsSOP DevelopmentContinuous Improvement

About the role

Key responsibilities & impact

Serve as first point of contact for all safety-related issues for assigned compounds within the therapeutic area
Lead all Global Patient Safety activities for assigned compounds and products
Support safety surveillance, signal management, safety-profile communication, benefit-risk assessment, regulatory agency responses and safety documents
Review clinical documents including Investigator Brochures, protocols and clinical study reports
Represent GPS on cross-functional Strategic Program Teams and chair Safety Management Teams
Lead safety strategy and coordinate support within GPS and with stakeholders
Lead cross-functional Safety Monitoring Team activities
Represent GPS on RSOC, IDMC, SPT and other internal and external cross-functional teams
Serve as delegate for the GPS Therapeutic Area Head, General Medicine, as needed
Develop safety strategies and planning for non-compound-specific GPS activities
Act as a medical-review resource 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

Requirements

What you’ll need

5+ years of total relevant experience in PV and/or relevant medical field with PharmD / PhD / MD degree
15+ years of total relevant experience in PV and/or relevant medical field or equivalent in lieu industry experience in drug safety
Significant experience with PSURs, DSURs and (d)RMPs, or clinical development with demonstrated achievements in safety
Demonstrated experience in specialty therapeutic areas incorporating advanced therapies, such as gene therapy, into pharmacovigilance practices
Ability to apply and provide critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities
Relevant clinical industry experience in the therapeutic area of interest
Thorough understanding of drug development and safety surveillance activities
Proven ability to lead and develop a diverse team of safety professionals
Ability to work across organizational levels and communicate safety viewpoints and findings effectively
Ability to utilize GPS safety database for medical case review and simple queries
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