Director, Global Patient Safety Sciences - General Medicine
Regeneron
August 19, 2026
Remote friendly (Tarrytown, NY)
United States
Medical Affairs
Discover Your Role
- Directly responsible for all aspects of Global Patient Safety activities for assigned compounds and products, including safety surveillance, signal management, communication of safety profile, benefit-risk assessment, regulatory agency query responses, safety documents (DSURs, PSURs, development RMPs, RMPs, etc.), and review of clinical documents (Investigator Brochures, protocols, clinical study reports, etc.).
- Lead cross-functional Safety Monitoring Team (SMT) activities.
- Represent Global Patient Safety for assigned compounds on cross-functional teams (RSOC, IDMC, Strategic Program Team (SPT), and external-member teams such as alliance partners and CROs).
- Proactively identify and develop safety strategies and planning for non-compound specific Global Patient Safety activities.
- Serve as a resource for medical review for complex ICSRs and other data sources.
- Participate in development and maintenance of relevant SOPs, working practices, and guides.
- Participate in continuous improvement and mentor junior safety scientists.
- Apply critical analysis of FDA, EU, and ICH pharmacovigilance guidelines/initiatives/regulations for clinical trial and post-marketing environments.
- Act as internal/external subject matter expert for assigned compounds.
- Lead and develop a diverse team of Safety Professionals.
- Communicate safety viewpoints/findings and recommended risk management/minimization.
- Utilize GPS safety database for medical case review and simple queries.
This Role Requires
- Minimum 10+ years relevant experience in PV and/or relevant medical field (including significant PSURs/DSURs/(d)RMPs) or equivalent drug safety experience.
- 5+ years relevant PV/medical experience with PharmD/PhD/MD.
- Clinical and/or industry experience in Oncology is a plus.
When & Where
- Work Location: Tarrytown, NY or Warren, NJ; 4 days per week on site.
Application Instructions
- Apply now.
- Directly responsible for all aspects of Global Patient Safety activities for assigned compounds and products, including safety surveillance, signal management, communication of safety profile, benefit-risk assessment, regulatory agency query responses, safety documents (DSURs, PSURs, development RMPs, RMPs, etc.), and review of clinical documents (Investigator Brochures, protocols, clinical study reports, etc.).
- Lead cross-functional Safety Monitoring Team (SMT) activities.
- Represent Global Patient Safety for assigned compounds on cross-functional teams (RSOC, IDMC, Strategic Program Team (SPT), and external-member teams such as alliance partners and CROs).
- Proactively identify and develop safety strategies and planning for non-compound specific Global Patient Safety activities.
- Serve as a resource for medical review for complex ICSRs and other data sources.
- Participate in development and maintenance of relevant SOPs, working practices, and guides.
- Participate in continuous improvement and mentor junior safety scientists.
- Apply critical analysis of FDA, EU, and ICH pharmacovigilance guidelines/initiatives/regulations for clinical trial and post-marketing environments.
- Act as internal/external subject matter expert for assigned compounds.
- Lead and develop a diverse team of Safety Professionals.
- Communicate safety viewpoints/findings and recommended risk management/minimization.
- Utilize GPS safety database for medical case review and simple queries.
This Role Requires
- Minimum 10+ years relevant experience in PV and/or relevant medical field (including significant PSURs/DSURs/(d)RMPs) or equivalent drug safety experience.
- 5+ years relevant PV/medical experience with PharmD/PhD/MD.
- Clinical and/or industry experience in Oncology is a plus.
When & Where
- Work Location: Tarrytown, NY or Warren, NJ; 4 days per week on site.
Application Instructions
- Apply now.