Senior Director, Medical Safety Assessment Physician
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
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.
- 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.
- Coordinate a group of Medical Safety Assessment Physicians (MSAPs) for 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.
General Product Support
- Lead safety activities and benefit-risk strategies for assigned BMS compound(s)/ program 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]).
- Coordinate a group of MSAPs for the 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.
- 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 DSUR, annual reports, and other periodic safety submissions.
- Represent WWPS at HA meetings. Actively drive 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 and approve 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/ program.
- Coordinate approach across multiple related assets or indications for 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, non-interventional safety studies.
- Ensure safety labeling adequately reflects emerging postmarketing safety profile.
- 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 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.
- Support hiring, orientation, management, mentorship, and development.
- Identify data gaps and Prioritize data acquisition. Provide input to strategic plans for safety differentiation of BMS products.
- Coordinate training to BMS employees on product safety profiles/issues.
- Provide input to due diligence and potential in-licensing opportunities as requested.
- Act as WWPS 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.
Degree / Experience Requirements
- MD/equivalent required. Postgraduate qualification or experience in internal medicine, immunology, oncology, or related specialty desirable.
- 5+ years in PV or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) is strongly preferred. Other relevant experiences & accomplishments considered, such as roles in clinical research, observational research & clinical practice experience.
Key Competency Requirements
- In-depth understanding of the drug development process.
- Broad knowledge of PV and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product.
- Practiced ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.
- In-depth understanding of regulatory requirements for safety assessment and action.
- Strong scientific analytical reasoning skills.
- Ability to work on multiple complex projects in parallel. Excellent attention to detail.
- Behavioral competencies necessary to work and lead within a complex matrix environment.
- Excellent verbal and written communication skills.
- Travel Required: Occasional travel within the US (eg, once every 2-3 months) and overseas (eg, once a year)
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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