Director, Medical Safety Assessment Physician

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 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 WWPS.

• 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 WWPS 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 product 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. Develop strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Document by Safety Topic Review/ Signal Report or other means of communication.

• Lead safety labeling activities for assigned products. 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.

• Support the EU QPPV 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.

Clinical Development

• Act as the global safety lead for assigned compounds in development. Provide safety lead support for global submission document production. Review draft summary documents.

• Lead medical safety development and execution of benefit-risk management strategies for assigned products.

• Provide safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plan (SAP), ICF, CSR, responses to HA or institutional review board (IR