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Safety Scientist, Expedited Safety Reports Specialist
2 months ago
Job Summary
We are seeking an Associate Safety Scientist to support the Expedited Safety Reporting team at Bristol Myers Squibb. As an Associate Safety Scientist, you will play a key role in ensuring the quality and integrity of safety data, working closely with safety scientists and medical review safety physicians to expedite the processing of SUSAR cases.
Key Responsibilities
- Perform high-quality data entry of Individual Case Safety Reports/SUSARs within the corporate safety database, including patient/study information, product details, and MedDRA coding of events, laboratory tests, and required data fields for case completeness.
- Complete and enter high-quality narratives for expedited safety reports to ensure all safety information is accurate, integrated, and current, and is submitted within regulatory timelines.
- Participate in the evaluation of serious adverse event reports from spontaneous reports, clinical trials, non-clinical reports, and scientific literature as needed.
- Assist in the review of new follow-up information and summarize information required for MRSP triage assessment of follow-up information.
- Review and QC all forms and documents pertaining to a case for errors and missing information.
- Identify additional information required from clinical databases and collaborate with MRSP to prepare queries to obtain additional information.
- Generate reports from the corporate safety database to prepare contextual summaries and analysis of similar events as required for expedited safety reports and other requirements.
- Coordinate all activities around the preparation, evaluation, review, and submission of expedited safety reports.
- Attach appropriate queries for missing/discrepant information and add follow-up letters as per WWPS standard operating procedures and work instructions.
- Consult MRSP and Expedited Safety Reporting (ESR) team, whenever there are queries related to SUSAR processing.
- Assist in reporting of SUSARs/ESRs to investigators and other stakeholders by coordinating with clinical operations and submissions team as required.
Requirements
- BSc/MSc Nursing; B. Pharm/M.Pharm/Pharm.D/BDS/BPT/MPT or Healthcare Degree preferred.
- 1-2 years of Drug Safety or clinical experience within the pharmaceutical industry is preferred.
About Us
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients fight serious diseases. We are committed to advancing science for human health and improving the lives of patients worldwide.
