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Safety Scientist, Expedited Safety Reporting
3 months ago
The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.Position Summary / ObjectiveThe 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.Position ResponsibilitiesPrepares 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.(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)Degree RequirementsBSc/MSc Nursing; B. Pharm/M.Pharm/Pharm.D/BDS/BPT/ MPT or Healthcare Degree preferred.Experience Requirements4 years experience in a pharmaceutical/healthcare or clinical development setting or 2-3 years of Drug Safety experience within the pharmaceutical industry.Key Competency RequirementsPossess 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.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
