Associate Director, Medical Safety Assessment Physician, Cell Therapy

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. Functional Area Description The Worldwide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety monitoring, safety reporting, contributing to benefit-risk assessment, risk management planning and strategy, execution of certain postmarketing commitments, and ensuring compliance with global regulatory requirements. Position Summary / Objective * Support safety activities and benefit-risk strategies for assigned BMS compounds/ program and chair the product Safety Management Team(s). * Prepare aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings. * Support evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation and document outcome. * Support 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 Qualified Person for Pharmacovigilance (PV) or other regional or local Qualified Person for PV relative to issues relating to assigned products. * 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. Position Responsibilities General Product Support * Support safety activities and benefit-risk strategies for assigned BMS compounds. * Prepare 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]). * Support 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. * Support 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 * Support the global safety lead for assigned compounds in development. Provide safety lead support for global submission document production. * Support medical safety development and execution of...