Executive Medical Director, Product Safety Physician Lead
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Job Description
Executive Medical Director leading product safety efforts for BeiGene’s oncology portfolio. Overseeing safety profiles, issues management, and communication of recommendations while collaborating across teams.
Responsibilities:
- Accountable for oversight of benefit/risk safety profile of allocated products through the product lifecycle
- Actively leads and enhances knowledge of safety profiles for allocated products
- Identifies and actively leads management of safety concerns for developmental and approved BeiGene products
- Chairs Safety Management Team (SMT) meetings for assigned products
- Actively leads communication of recommendations to labeling group/other stakeholders
- Leads the review of issue data and closure on recommendations
- Accountable for the content of safety sections of the Development Safety Update Report (DSUR)
- Actively leads safety Issue Assessment and documentation
Requirements:
- MD (or internationally recognized equivalent)
- 10+ years pharmaceutical/biotechnology industry experience in Clinical Research, Clinical Development
- At least 6 years in pharmacovigilance
- Accredited fellowship with 1-year clinical experience with patients in a relevant therapeutic area specialty
- Significant knowledge of general medicine
Benefits:
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
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