Bristol-Myers Squibb Company

Safety Scientist - Expedited Safety Review

Location
Hopewell, NJ, US
Posted
May 12, 2018
Ref
R1120841
Required Education
Bachelors Degree
Position Type
Full time
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