About this role
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. 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 Provide strategic oversight & delivery of medical safety assessment for assets in therapeutic area (TA) by effective management of safety physician team. Oversee safety activities and benefit-risk strategies for assigned compound(s)/ program(s) and chair the product/TA Safety Management Team (SMT). Oversee, Review, and Approve aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings. Oversee team in evaluation & management of signals emerging from any data source. Guide strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Ensure documentation by Safety Topic Review/Signal Report or other means of communication. Approve safety labeling activities for assigned products. Provide Safety Subject Matter Expertise for input to regulatory product labeling. Drive change in the organization and adoption of new processes. Assist the MSA TA Head in developing and maintaining state-of-the-art PV processes and procedures within BMS R&D and WWPS. Position Responsibilities General Product Support Oversee safety activities and benefit-risk strategies for assigned compound(s)/ program(s) and chair the product/TA Safety Management Team (SMT). Oversee, Review, and Approve 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]). Oversee team in evaluation & management of signals emerging from any data source. Guide strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Ensure documentation by Safety Topic Review/Signal Report or other means of communication. Approve safety labeling activities for assigned products. Provide Safety Subject Matter Expertise for input to regulatory product labeling. 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 Oversee the global safety strategy for assigned compounds in development. Support global submission document production. Review final summary documents. Oversee medical safety development and execution of benefit-risk management strategies for assigned products. Review safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plans (SAP), ICF, clinical study reports (CSR), responses to health authority (HA) or institutional review board (IRB)/ ethics committee (EC) queries. Oversee development of safety risk language, risk management strategy, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, safety- focused publication development. Ensure medical safety review of DSUR, annual reports, and other periodic safety submissions. Represent WWPS at HA meetings. Actively drive benefit-risk strategies for pre-submission meetings, Advisory Committee meetings, Scientific Advice meetings, DMC meetings, etc. Postmarketing Support Oversee the lifecycle safety strategy for assigned marketed compounds and support global postmarketing safety activities and submissions. Provide medical safety, benefit-risk input and approve DSUR/PBRER, product renewal submissions, postmarketing study documents, and reports, responses to HA queries. Provide medical safety oversight of and execution of risk management strategies and risk management plan (RMP) elements for assigned products. Oversee safety signal evaluation & management. Review and Approve reports on safety signals (ie, Safety Topic Reviews/ Signal Reports) and ad hoc regulatory responses. Provide postmarketing safety study guidance to other groups including epidemiology and medical affairs, including but not limited to investigator sponsored research/ trials (IST), epidemiology studies, and non-interventional research. Ensure safety labeling adequately reflects emerging postmarketing safety profile. Department Activities Drive change in the organization and adoption of new processes. Assist the MSA TA Head in developing and maintaining state-of-the-art PV processes and procedures within BMS R&D and WWPS. Support preparation for regulatory inspections with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates. Assist the team and senior management in all forms of issue management and crisis management. Liaise with all TA staff and maintain an effective and collaborative patient safety team. Hire, Orient, Manage, Mentor, and Develop staff. Cross-Functional Activiti