Aircraft Maintenance Manager overseeing compliance with aviation regulations and maintenance procedures for airworthiness. Leading training activities and ensuring safety standards with a focus on quality and efficiency.
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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