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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 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 (IRB)/ ethics committee (EC) queries.
Lead 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.
Perform medical safety review of development update safety reports, annual reports and other periodic safety submissions.
Support safety strategy preparation for pre-submission meetings, Advisory Committee meetings, Scientific Advice meetings, DMC meetings, etc.
Postmarketing Support
Act as the safety lead for assigned marketed compounds and support global postmarketing safety activities and submissions.
Provide medical safety, benefit-risk input for safety aggregate reports, product renewal submissions, postmarketing study documents and reports, responses to HA queries.
Lead medical safety oversight of and execution of risk management strategies and RMP elements for assigned products.
Lead safety signal evaluation & management. Prepare and review 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 (ISR), epidemiology studies, and non-interventional safety studies.
Ensure safety labeling adequately reflects emerging postmarketing safety profile.
Department Activities
Lead process improvement projects. Assist the MSA TA Head/Lead in developing and maintaining state-of-the-art PV processes and procedures within BMS R&D and PS.
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.
Support hiring & orientation.
Cross-Functional Activities
Provide input to strategic plans for safety differentiation of BMS products.
Prepare and Provide training to BMS employees on product safety profiles/issues.
Act as PS liaison for assigned products with BMS functions (Legal, BD, Operations, Marketing, etc.).
Support manufacturing quality. Co-Author integrated health hazard assessments.
Develop communications of safety data & interpretation to BMS and external parties, globally.