Responsable HSE chargé d'élaborer et de mettre en œuvre les politiques de santé, sécurité et environnement au sein d'une entreprise en croissance. Superviser les actions de prévention et gérer les risques industriels.
About the role
- Senior Manager of Global Patient Safety focusing on safety strategies and risk management for clinical trials. Responsible for signal detection, safety document preparation, and representing GPS in cross-functional teams.
Responsibilities
- Complete signal detection activities in line with approved safety surveillance plan
- Perform signal evaluation for any identified signals and author the safety evaluation reports
- Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries
- Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds
- Participate in other risk management activities as appropriate for assigned compounds
- Represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron
- Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents
Requirements
- Minimum a Master's, PhD, or PharmD
- 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
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