Bristol Myers Squibb Safety Scientist - Expedited Safety Review in Pennington, New Jersey

Title: Safety Scientist - Expedited Safety Review

Location: NA-US-NJ-Pennington

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.

Qualifications:

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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