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 group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.
Supports Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams. Independently performs core signal detection activities and elevate program or portfolio issues impacting key Safety Management Team (SMT) programs, priorities, resources, and milestones. Authors safety data query responses, author and contribute to specific PV sections of the Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR). Ensures pharmacovigilance regulatory compliance.
Mentors less experienced scientists and teams in aspects of project management, SMT requirements, core signal detection, safety data query responses, and contributions to specified PV sections of the PBRER and DSUR, as appropriate to meet individual or group of SMT/sub-team needs.
General Product Support
Collaborates with Medical Safety Assessment Physician (MSAP) leading signal detection activities for a product’s emerging safety profile.
Provides strong medical writing support for PV sections of aggregate safety documents (eg, DSUR, PBRER) and analyzes data for the RSI section of the IB. Collaborates with MSAP to author and analyze data for ad hoc responses to health authorities.
Contributes to the development of the strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Documents signal by Safety Topic Review/ Signal Report.
Analyzes data and prepare documentation to support label updates for assigned products.
Supports Safety for input to regulatory product labeling.
Supports the EU QPPV or other regional or local Qualified Person for safety issues relating to assigned products.
Applies knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Share with individuals and teams on these applied learnings.
Clinical Development & Post Marketing Product Support
Leads core surveillance activities, signal assessment according to the product stage of development for multiple compounds, with oversight, as needed.
Leads Safety Data Review (SDR) Teams in the review and evaluation of clinical data to support signal detection. Appropriately elevates issues impacting key SMT activities, milestones, and documents to the SMT Chair with limited or no oversight, as needed.
Contributes to specified PV sections of the DSURs, PBRERs and safety data query responses to HAs including coordination and integration of input from other functional groups, as needed to support responses to ad hoc queries, with limited or no oversight, as needed.
Provides guidance to junior scientists’ for reviewing and authoring of safety data/ad hoc queries.
Contributes to the strategy and perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data.
Provides input for the strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Partner with SMT Chair on the evaluation & management of signals emerging from any data source. Authors the Safety Topic Review/ Signal Report and tracks signals for other means of communication, with limited or no oversight, as needed.
Facilitate the review and evaluation of SARs for inclusion in the IB RSI, including presentation to SMT to ensure alignment. Author the IB RSI table for multiple products with limited or no oversight.
Author documentation to support safety labeling updates to ensure labeling adequately reflects the emerging post-marketing safety profile, with limited or no oversight.
Participates in improvement projects. Assist the PV scientist team Lead in developing and maintaining state-of-the-art PV processes and procedures within BMS R&D and WWPS.
Supports preparation for regulatory inspections and audits for evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.
Assists the team and senior management in all forms of issue management and crisis management.
Liaises with all TA staff and maintain an effective and collaborative safety team.
Supports hiring & orientation.
Cross Functional Activities
Supports process improvement and cross-functional initiatives for Safety Science including SOPs and Procedural Documents.
Supports the development of strategic plans for safety differentiation of BMS products.
Builds cross functional relationships with SMT membership and stakeholders.
Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent combination of relevant education and professional experience.
6 - 8 years relevant Pharmacovigilance/Pharmaceutical Industry experience; Ability to mentor others.
Key Competency Requirements
Partners with Medical Safety Assessment Physician (MSAP) to plan, lead, and advance programs.
Good working understanding of medical concepts and some familiarity with safety activities in drug development and post-marketing and global safety health authority requirements.
Good working understanding of team priorities and milestones. Ability to manage timelines and quality of work using organizational and interpersonal communication skills. Appropriately communicates items that could impact timelines or quality.
Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
Ability to work well in cross-functional teams.
Routinely takes initiative
Ability to collaborative and communication skills with scientific subject matter.
Ability to make good decisions based upon a mixture of analysis, knowledge, experience, and judgment.
Attention to detail along with strong scientific, analytical and conceptual skills and the ability to reach reasoned conclusions. Ability to understand complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, post-marketing reports, scientific literature, and regulatory documents).
Good understanding aspects and methods for data analysis, interpretation and presentation.
Possess good working skills in MS Word, Excel and PowerPoint, including statistics
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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