Bristol Myers Squibb Safety Scientist - Expedited Safety Review in Pennington, New Jersey
Title: Safety Scientist - Expedited Safety Review
Job Number: 1703601
Key Responsibilities and Major Duties
Prepares high-quality narrative summaries for expedited safety reports incl. responsibility to ensure all safety information is accurate, integrated and current, and is submitted within regulatory timelines.
Participates in the evaluation of serious adverse event reports from spontaneous reports, clinical trials, non-clinical reports and scientific literature.
Provides technical support to GPV&E medical review safety physicians (MRSP) including review and interpretation of source documents.
Identifies additional information required from investigators and collaborate with MRSP to prepare queries to obtain additional information.
Utilizes BMS safety and clinical databases to prepare contextual summaries for expedited safety reports.
Coordinates all activities around the preparation, evaluation, review and submission of expedited safety reports.
Reviews and comments on documents and line listings from GPV&E, other BMS departments, and other drug development/ marketing partners and contractors.
Follows BMS GPV&E and R&D SOPs, drug safety coding conventions, and work-aids.
Performs analysis of Similar Events for potential DILI and events of special interest cases.
Serves as a resource for GPV&E to provide SUSAR-related information; helps develop and participate in and/or lead teams involved with developing or revising GPV&E SOPs.
Ad Hoc member of Medical Surveillance Team.
Works with GPV&E vendors & partners providing oversight/guidance for the ESR/SUSAR process.
List of minimum requirements
B.S.N./RN, B.A./B.S./M.S. (Life Sciences); B.S. Pharm./R.Ph./Pharm.D. or equivalent.
Experience – 4 years experience in a clinical development setting or 1-3 years Safety experience within the pharmaceutical industry.
Possess medical writing skills to produce accurate, concise, medically sound expedited reports.
Experience using a drug safety database to capture adverse events.
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 and the ability to lead a team.
Strong prioritization skills to ensure that processes, procedures and best practices are consistent across GPV&E; 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 apply sound analytical thinking and database query skills to gather, review, summarize and evaluate critical information in a timely manner.
Ability to apply medical, scientific and clinical knowledge in reviewing safety-related documents (e.g. protocols, investigator brochures, product labels, relevant source documents) and incorporating key concepts to clearly present the reported events, and in turn, maintain patient safety.
Knowledge and understanding of Health Authority Regulations worldwide, how to access them and when to refer to them.
Ability to support GPV&E Vision and Mission through an understanding of the impact and implications of daily work on all customers of the Expedited Safety Report Group.
In-depth knowledge of computer applications.
Project planning skills.
Working Knowledge of CARA/Prism and ability to find a retrieve documents from CARA/PRSIM
Software that must be used independently and without assistance (e.g., Microsoft Suite)
Microsoft Suite, AWARE, MedDRA, J-Review, Eclipse, SharePoint, MS Outlook, MS Communicator, MS 365, CARA/PRISM
Bristol-Myers Squibb is an equal opportunity employer - Minorities/Females/Protected Veterans/Disabled
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