Safety Scientist, Expedited Safety Reporting
1 week ago
**Working with Us**
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
**Functional Area Description**
The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines. This includes all pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.
**Position Summary / Objective**
Support case processing of SUSARs/expedited safety reports in BMS Safety Database. Closely work with Safety Scientists and Medical Review Safety Physicians within in WorldWide Patient Safety (WWPS) in expediting the processing of SUSAR cases
**Position Responsibilities**
- Perform high quality data entry of Individual Case Safety Reports/SUSARs within corporate safety database including patient/study information, product details and perform MedDRA coding of events, laboratory tests and all required data fields for case completeness.
- Complete and enter high-quality narrative 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 review of new follow-up information and summarize information required MRSP triage assessment of follow-up information.
- Review and QC all forms and documents pertaining to a case for errors, missing information.
- Identify additional information required from clinical database and collaborate with MRSP to prepare queries to obtain additional information.
- Generate reports from corporate safety database to prepare contextual summaries/Analysis of Similar Events as required for expedited safety reports and for 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 stake holders by coordinating with clinical operations and submissions team as required.
- Responsible for escalating the issues or tasks outside the normal scope of work.
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
**Degree Requirements**
BSc/MSc Nursing; B. Pharm/M.Pharm/Pharm.D/BDS/BPT/ MPT or Healthcare Degree preferred.
**Experience Requirements**
1-2 years of Drug Safety or clinical experience within the pharmaceutical industry is preferred.
**Key Competency Requirements**
- Experience working in a post-marketing safety or clinical trial setting (i.e., CRO, pharmaceutical company and academic setting).
- Experience working in teams, including supporting other team members when necessary.
- Strong prioritization skills to ensure that processes, procedures and best practices are consistent across WWPS; and that all applicable regulatory requirements are met in a timely manner with high quality.
- Ability to make constructive recommendations to improve processes.
- Demonstrates the ability to multi-task, and flexibility to meet changing business priorities.
- Ability to collaborate within multi-disciplinary team on drug safety-related issues including informing safety physicians and scientists within the therapeutic area on case-related issues.
- Ability to support WWPS Vision and Mission through an understanding of the impact and implications of daily work on all customers of the Expedited Safety Reporting team.
**Uniquely Interesting Work, Life-changing Careers**
**On-site Protocol**
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined
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