Executive Director, Medical Safety Assessment Princeton

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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 Activities

Identify data gaps and Prioritize data acquisition. Provide input to strategic plans for safety differentiation of BMS products.

Oversee and/or provide training to BMS employees on product safety profiles/issues.

Provide input to due diligence and potential in-licensing opportunities as requested.

Act as WWPS TA liaison for assigned products with BMS functions (Legal BD Operations Marketing etc.).

Support manufacturing quality. Review integrated health hazard assessments.

Review communications of safety data & interpretation to BMS and external parties globally.

Leadership Behaviors

Communicate the companys vision values and strategies in a way that builds the understanding and commitment of others.

Facilitate skill development by coaching others and sharing expertise.

Effectively motivate and retain top talent offer praise and recognize contributions.

Provide team members with regular and constructive performance feedback encourage sharing better practices and ideas.

Resolve conflict within the team so that performance and engagement are not impacted.