Medical Safety Manager

About the Role

The Manager, Global Medical Safety supports the Global Medical Safety (GMS) team in assessing, tracking, and documenting the benefit-risk profile of marketed and clinical-stage products. This role oversees outsourced safety responsibilities, develops aggregate reports, coordinates safety review meetings, and ensures cross-functional collaboration to deliver timely safety deliverables. It also involves providing scientific support for safety surveillance and signal detection, managing safety reporting processes, preparing for audits, and maintaining SOPs and safety documentation.

Responsibilities

• Manage daily global medical safety operations and delegated tasks
• Oversee vendor safety responsibilities and ensure compliance with safety plans
• Handle deviation and CAPA activities related to safety reporting
• Develop training materials and lead new hire adverse event (AE) and safety information (SI) training
• Plan and coordinate Safety Review Committee (SRC) and Safety Review Team (SRT) meetings
• Provide scientific support for safety surveillance and signal detection
• Contribute to safety reports and ensure timely regulatory submissions
• Support investigational products, clinical programs, and audits
• Maintain SOPs and safety documentation

Requirements

• Advanced life science degree
• At least 3 years of industry experience, including 2 years in pharmacovigilance (preferred)
• Project management skills and strong attention to detail
• Ability to work independently and collaboratively across teams
• Strong communication skills
• Knowledge of regulatory safety reporting, Good Clinical Practice (GCP), and pharmacovigilance standards
• Proficiency in Microsoft Office
• Experience working with external partners