Director, Medical Safety Assessment Physician, Neuroscience

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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 with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary * Lead safety activities and benefit-risk strategies for assigned BMS compounds/ program and chair the product Safety Management Team(s). * Oversee, prepare and/or review aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings. * Lead team in the evaluation & management of safety signals emerging from any data source. Develop strategy for signal evaluation and document outcome. * Lead safety labeling activities for assigned products / program. Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/ provide input at cross-functional labeling team meetings and provide regional safety labeling support. * Lead process improvement projects. Assist the MSA Therapeutic Area (TA) Head/Lead in developing and maintaining state-of-the-art PV processes and procedures within BMS R&D and PS. * Support the EU Qualified Person for Pharmacovigilance (PV) or other regional or local Qualified Person for PV relative to issues relating to assigned products. * Provide input to R&D publication strategy/ plan & ensure safety input to publications/ presentations * Actively drive safety strategy preparation and Represent PS at Health Authority (HA) and Data Monitoring Committee (DMC) meetings. * Ensure that the above tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements and BMS cost effectiveness goals. * Promote collegiality and teamwork among peers. Mentor/support colleagues as a positive change agent. Duties/Responsibilities General Product Support * Lead safety activities and benefit-risk strategies for assigned BMS compounds and chair the products SMT(s). * Oversee, prepare and/or review aggregate safety review documents (eg, Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (eg, protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]). * Lead team in evaluation & management of signals emerging from any data source (eg, case-series, literature review, Health Authority (HA)/ claims database). Document by Safety Topic Review/ Signal Report or other means of communication. * Lead safety labeling activities for assigned products. Support Safety input for regulatory product labeling. Participate/ provide input at cross-functional labeling team meetings and provide regional safety labeling support. * Support the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products. * Support R&D publication strategy/ plan & ensure safety input to publications/ presentations. Clinical Development * Act as the global safety lead for assigned compounds in development. Provide safety lead support for...