Senior Manager, Pharmacovigilance Scientist
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.
Support Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams. Appropriately perform core signal detection activities and elevate program or portfolio issues impacting key MST programs, priorities, resources, and milestones with appropriate oversight. Author responses for safety data queries and contribute to specified PV sections of the Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR). Ensure pharmacovigilance regulatory compliance with oversight, as needed.
General Product Support
Supports Medical Safety Assessment Physician (MSAP) leading signal detection activities for a product's emerging safety profile.
Prepare/write PV sections of aggregate safety documents (eg, DSUR, PBRER) and analyze data for the RSI section of the IB. Write and analyze data for ad hoc responses to health authorities, with oversight.
Execute strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Document signal by Safety Topic Review/ Signal Report.
Analyze data and prepare documentation to support label updates for assigned products, with oversight.
Support Safety input for regulatory product labeling.
Support the EU QPPV or other regional or local Qualified Person for safety issues relating to assigned products.
Working 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
Perform core surveillance activities, signal assessment according to the product stage of development for a multiple compounds, with oversight, as needed.
Lead Safety Data Review Meetings (SDRM) in the review and evaluation of clinical data to support signal detection. Appropriately elevate issues impacting key SMT activities, milestones, and documents to the SMT Chair with 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 oversight, as needed.
Perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data.
Executes 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 oversight, as needed.
Perform 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 less complex products with oversight, as needed.
Author documentation to support safety labeling updates to ensure labeling adequately reflects the emerging postmarketing safety profile, with oversight as needed.
Support preparation for regulatory inspections and audits with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.
Support hiring & orientation.
Cross Functional Activities
Support process improvement and cross-functional initiatives for Safety Science including SOPs and Procedural Documents.
Builds cross functional relationships with SMT membership and stakeholders
Degree / Experience Requirements
Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent combination of relevant education and professional experience.
3 – 5 years relevant Pharmacovigilance/Pharmaceutical Industry experience.
Key Competency Requirements
Working understanding of medical concepts and some familiarity with safety activities in drug development and postmarketing and global safety health authority requirements.
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.
Good collaborative and communication skills with scientific subject matter.
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, postmarketing reports, scientific literature, and regulatory documents).
Understand 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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