Director, 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. Independently perform core signal detection activities and elevate program or portfolio issues impacting key Safety Management Team (SMT) programs, priorities, resources, and milestones. Author 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). Ensure pharmacovigilance regulatory compliance.
Supervise and mentor 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/subteam needs.
General Product Support
Partners with Medical Safety Assessment Physician (MSAP) leading signal detection activities for a product's emerging safety profile.
Independently provides medical writing support for 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.
Designs strategy in collaboration with MSA and executes strategy for signal evaluation (eg, case-series, literature review, HA/claims database). Document signal by Safety Topic Review/Signal Report.
Provides input into strategy, analyze data, and prepare documentation to support label updates for assigned products.
Support Safety for input to regulatory product labeling.
Support the EU QPPV or other regional or local Qualified Person for safety issues relating to assigned products.
Proactively applies knowledge of product goals, strategy, drug development state milestones, partnership agreement, health authority (HA) commitments, and individual functional area responsibilities. Mentor individuals and teams on these applied learnings.
Clinical Development & Post Marketing Product Support
Leads the strategy for core surveillance activities, signal assessment according to the product stage of development for multiple complex compounds, with no oversight.
Lead Safety Data Review (SDR) Teams 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 no oversight.
Authors or oversees development of content for safety 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.
Ability to mentor and supervise other scientists’ reviewing and authoring of safety data/ad hoc queries.
Develop the strategy and perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data. Provide advice and mentoring to scientists of summaries, evaluations, and conclusions.
Develops strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Partner with SMT Chair on the development of strategy for 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, independently.
Lead the review and evaluation of SARs for inclusion in the IB RSI andincluding presentation to SMT to ensure alignment. Author the IB RSI table for multiple complex products.
Lead the authoring of documentation to support safety labeling updates to ensure labeling adequately reflects the emerging postmarketing safety profile, independently.
Lead process 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 as a Subject Matter Expert for assigned products for regulatory inspections and audits 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 safety team.
Support hiring, orientation, management, mentorship, and development.
Cross Functional Activities
Participate in process improvement and cross-functional initiatives for Safety Science including SOPs and Procedural Documents.
Participate in the development of strategic plans for safety differentiation of BMS products.
Builds cross functional relationships with SMT membership and stakeholders.
Role Model for PV Science team to encourage development; leads by example.
Provide team members with feedback and sharing best practices and ideas.
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.
Minimum 10 years relevant Pharmacovigilance/Pharmaceutical Industry experience; Demonstrated ability to mentor and coach others.
Key Competency Requirements
Partners with Medical Safety Assessment Physician (MSAP) to plan, lead, and advance programs.
In-depth understanding of medical concepts, drug development, pharmacovigilance, risk management and global regulatory safety and risk management health authority requirements and submission milestones.
In-depth understanding of project planning methods; demonstrated ability to manage timelines and to prioritize; ability to align operational milestones and activities with operational representatives in other functional areas. Appropriately escalates issues that could impact activity timelines or quality.
Skilled at being 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 effectively lead and work well within cross-functional teams, using strong organizational, facilitation, and interpersonal communication skills.
Takes initiative, ability to self-supervise, and act independently to identify/resolve program level issues.
Strong collaborative and communication of scientific subject matter.
Strong ability to make good decisions based upon a mixture of analysis, knowledge, experience, and judgment.
Attention to detail along with excellent scientific, analytical and conceptual skills. Demonstrated ability to understand, research, independently investigate, interpret, and reach reasoned conclusions regarding complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, postmarketing reports, scientific literature, and regulatory documents)
Strong understanding of aspects and methods for data analysis, interpretation and presentation.
Personally committed and open to coaching and feedback to improve self.
Demonstrated excellent knowledge and use of MS Office (or other equivalent BMS office suite) programs such as Excel and PowerPoint; applying technical skills to analyze and summarize scientific-medical-safety data, and to portray and summarize scientific-medical-safety concepts and teach these capabilities to others.
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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