Medical Safety Review Expert
2 weeks ago
At Bristol Myers Squibb, we are committed to transforming patients' lives through science.
We are currently seeking an Associate Director, Medical Safety Review to join our team in this exciting opportunity
About the RoleThis is a site-essential role requiring 100% of shifts onsite at your assigned facility. As a member of our Worldwide Patient Safety group, you will be responsible for ensuring the safety of our medicines and contributing to the development of optimal solutions for safety-related issues.
You 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. Your expertise will also support signal detection and risk management-related activities.
In this role, you will have the opportunity to work closely with WWPS personnel from other functions, Clinical Development, and Business Partners to evaluate the safety profile of BMS compounds. You will identify potential safety signals and inform the MSAP of all potentially important cases and issues.
Responsibilities- Provide 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).
- Determine regulatory reportability of ICSRs for assigned products and provide oversight of single case processing vendor re: medical review for products of responsibility if applicable.
- Lead Case Processing & Review meetings for assigned products and support signal detection and risk management requirements globally for assigned products throughout the product life cycle.
- Execute RMP re: ICSR/medical review-related Pharmacovigilance (PV) activities and ensure special health authority requirements are met pertaining to medical assessment and submission of ICSRs.
To be successful in this role, you will need:
- A minimum of 2-4 years in clinical practice or relevant setting.
- A minimum of 1-3 years of pharmaceutical industry experience.
- 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.
We offer a competitive salary range of $120,000 - $180,000 per year, depending on location and experience. Additionally, we provide excellent benefits, including medical, dental, and vision insurance, as well as a 401(k) plan and paid time off.
We are committed to diversity and inclusion and strive to create a workplace that reflects the communities we serve. We encourage applications from qualified candidates who share our values and passion for improving patient outcomes.
Please note that this is a site-essential role requiring 100% of shifts onsite at your assigned facility. If you are interested in this opportunity, please apply through our website.
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