Medical Safety Review Lead
4 weeks ago
Job Summary
The Associate Director, Medical Safety Review will provide high-quality medical review of Individual Case Safety Reports (ICSRs), including determination of regulatory reportability of clinical trial cases and certain post-marketing reports. The role supports signal detection and risk management-related activities.
Key Responsibilities
- Provides high-quality medical assessment of ICSRs with particular attention to critical cases (SUSARs, AEs of Interest, potential Drug-Induced Liver Injury [pDILI], pregnancy, any critical events).
- Provides seriousness, causality, and expectedness assessment and determines regulatory reportability of ICSRs for assigned products.
- Serves as a medical expert in signal detection and risk management-related activities.
- Ensures complete and timely reporting of ICSRs to regulatory authorities globally for products of responsibility.
- Collaborates with Quality, Standards, and Training teams to ensure consistency of work practices and SOPs.
- Partners with WWPS personnel from other functions (Case Management, PV Scientists, Expedited Safety Reporting [ESR] Safety Scientists, and Medical Safety Assessment Physicians [MSAP]) in evaluating the safety profile of BMS compounds of responsibility.
Requirements
- MD or Equivalent.
- Board certification and medical specialty preferred.
- Minimum 2-4 years in clinical practice or relevant setting.
- Minimum 1-3 years of pharmaceutical industry experience.
Competencies
- Knowledgeable and skilled in medicine and pharmaceutical product safety.
- Experience applying medical knowledge to the interpretation of individual case review; experience with reporting of individual adverse events.
- Previous experience in the safety field and/or pharmaceutical industry preferred.
- Experience working in a team environment, including supporting other team members when necessary; promoting collegiality and teamwork among peers.
About Bristol Myers Squibb
Bristol Myers Squibb is committed to transforming patients' lives through science. With a single vision as inspiring as 'Transforming patients' lives through scienceTM ', every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.
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