Patient Safety Medical Director
$276,000–$414,000 year
HybridBoston, Massachusetts, United States
Job Summary
Lead all safety and benefit-risk activities for assigned products from first-in-human trials through commercialization, coordinating signal detection and overseeing Risk Management Plans. Provide leadership for Safety Teams, developing and implementing Risk Management procedures while collaborating with Clinical Leaders and Regulatory Affairs on NDA submissions. Conduct medical reviews of aggregate and individual post-marketing and clinical trial adverse event reports, evaluate safety data from toxicology and non-clinical sources, and prepare Periodic Safety Updates and labeling documents. Serve as Subject Matter Expert in SOP development and facilitate staff growth within the department.
Required Qualifications
- Doctorate in Medicine (M.D.)
- 7 years of work experience
- Experience in Pharmacovigilance
- 5 years of supervisory/management experience
- Broad and comprehensive knowledge of General Medicine
- Extensive knowledge of GCP, ICH and Global regulations
- Strong leadership skills with the ability to communicate effectively in a matrix environment
- Experience in the critical evaluation and interpretation of data, with ability to synthesize into coherent messaging
- Comprehensive knowledge of Benefit-Risk strategies and decision-making
- Ability to multi-task, adeptly handling multiple demands
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