Senior Safety Scientist Expedited Safety Reporting

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary

The function of the ESR Scientist group is to work in conjunction with the Vendor SUSAR Support Team and Medical Review Safety Physicians (MRSP) to identify and report ESRs within regulatory agency timelines worldwide.

Responsibilities


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 WWPS 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 WWPS, other BMS departments, and other drug development/ marketing partners and contractors.
Follows BMS WWPS and R&D SOPs, drug safety coding conventions, and work-aids.
Performs analysis of Similar Events for SUSAR reports, potential DILI and events of special interest cases.
Serves as a resource for WWPS to provide SUSAR-related information; helps develop and participate in and/or lead teams involved with developing or revising WWPS SOPs.
Works with WWPS vendors & partners providing oversight/guidance for the ESR/SUSAR process.
Leads Training for New ESR Scientist and mentors ESR Safety Scientist without requiring direct guidance from Manager.
Provides input on Pharmacovigilance Agreements regarding SUSAR Process


Education


6 years experience in a clinical development setting or 4 years Safety experience within the pharmaceutical industry.


Knowledge/Skills


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 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 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 WWPS Vision and Mission through an understanding of the impact and implications of daily work on all customers of the Expedited Safety Reporting team.
Project planning skills.


Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1522124_EN

Updated: 2020-02-28 00:00:00.000 UTC

Location: Princeton,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

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