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Director, Global Medical Safety
4 days a week onsite
Reporting to the Vice President of Global Medical Safety, this role involves leading and collaborating with teams to evaluate, monitor, and document the benefit-risk profile of products in development and on the market. Key responsibilities include contributing to safety sections of aggregate reports (e.g., DSUR, PBRER, ASR), facilitating cross-functional Safety Review Team (SRT) meetings, managing signal detection activities, and allocating appropriate resources to clinical development and product registration efforts.
Key Responsibilities:
- Lead and manage safety surveillance, signal detection, and risk assessments for assigned products.
- Oversee the preparation and review of safety sections in aggregate reports and regulatory documents.
- Organize and facilitate Safety Review Team (SRT) meetings and ensure effective cross-functional collaboration.
- Provide guidance on safety-related aspects of early-stage clinical trials and product lifecycle management.
- Ensure compliance with global pharmacovigilance regulations and internal processes.
Requirements:
- Bachelor’s degree in Life Sciences or Healthcare; advanced degree (e.g., PharmD) preferred.
- Minimum of 10 years’ experience in Pharmacovigilance or related field.
- Knowledge of clinical development processes and global safety regulations.
- Strong analytical skills and ability to manage safety data and reports.
- Excellent communication, organizational, and collaboration skills.
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