Bristol Myers Squibb Senior Safety Scientist - Expedited Safety Review in Hopewell, New Jersey
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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.
The function of the Sr. Safety Scientist is to work in conjunction with the Vendor Chennai SUSAR Support Team and Medical Review Safety Physicians (MRSP) to identify and report ESRs within regulatory agency timelines worldwide. In addition to training of New ESR-Scientists and participating and leading special projects within GPV&E
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.
Leads project initiatives for SUSAR process improvement within GPVE SME for ALL SUSAR Processes
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
Excellent Communication Skills in writing and Speaking
List of requirements:
B.S.N./RN, B.A./B.S./M.S. (Life Sciences); B.S. Pharm./R.Ph./Pharm.D. or equivalent.
6+ years of experience in a clinical development setting or 4+ years Safety experience within the pharmaceutical industry.
Competencies – knowledge, skills, abilities, other:
Possess excellent medical writing skills to produce accurate, concise, medically sound expedited reports.
Subject Matter Expert (SME) for drug safety database to capture serious adverse events.
Experience working in a post-marketing safety or clinical trial setting (i.e., CRO, pharmaceutical company and academic setting).
Experience working and leading teams, including supporting other team members when necessary and the ability to lead a team.
Strong leadership and project planning skills.
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 handle high case load while managing individual projects.
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 implement new processes with minimal guidance from Manager.
Knowledge of software applications - Microsoft Suite, AWARE, MedDRA, J-Review, Eclipse, Sharepoint, MS Outlook, MS Communicator, MS 365 and CARA/PRISM. Knowledge of CARA/Prism and ability to find a retrieve documents from CARA/PRSIM is preferred.
Excellent 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.
Proactively identify areas for improvement with and outside of ESR Scientist team.
Knowledge and understanding of Health Authority Regulations worldwide, how to access them and when to refer to them and ability to provide guidance to other ESR-Scientists.
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.
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, disability or protected veteran status.