Senior Director, Head Pharmacovigilance Scientist, IN&F
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us
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 postmarketing commitments and ensuring compliance with global regulatory requirements.
Manage a team of scientists who support cross-functional Safety Management Teams (SMTs) and assigned sub-teams, such as Safety Data Review (SDR) Teams, and participate in related PV and product development sub-team(s). Appropriately elevate program or portfolio issues impacting key SMT programs, priorities, resources, and milestones. Mentor individuals and teams in aspects of project management, SMT requirements, core signal detection, and safety data/Health authority queries as appropriate to meet individual or group of SMT/sub-team needs.
General Product Support
Partners with Medical Safety Assessment (MSA) Head to plan, lead, and advance programs and talent
Oversees and manage resources to ensure adequate support to Medical Safety Assessment and assigned sub-teams, such as Safety Data Review (SDR) Teams activities relating to monitoring and management of Product's emerging safety profile
Ensures analytic support resources are available to MSA in their evaluation of the overall safety profiles of BMS assets, as appropriate. Provides guidance to relevant Safety Management Teams
Oversees the development, maintenance, and availability of signal detection and analytic tools and resources
Oversees and manage compound level support provided by Safety Scientists ensuring consistency across therapeutic area
Clinical Development & Post Marketing Product Support
Ensures safety scientist support to MSA for the management of BMS assets’ benefit/risk profile, development of safety content and risk sections in aggregate safety reports, and events of interest for surveillance
Oversees signal detection strategies of compounds in development/marketed products and provide guidance to Safety Scientist Team on study related deliverables and safety document (DSUR, IB RSI, PBRER, Product labeling).
Oversees and supports the framework for safety surveillance activities, signal assessment and regulatory safety requests for the TA
Reviews safety sections / safety deliverables to ensure consistency and compliance with current requirements
Oversees and manage compound level support provided by Scientists such as periodic signaling, periodic reports, ad hoc safety topic reports and labeling discussions ensuring consistency across the therapeutic area
Cross Functional Activities
Provides strategy for process improvement and cross-functional initiatives for Safety Science including SOPs and Procedural Documents.
Drives interactions with key line functions in support of safety activities between Safety Science and Stakeholders
Provide input to strategic plans for safety differentiation of BMS products
Builds cross functional relationships with SMT membership
Facilitate skill development by coaching others and sharing expertise.
Provide team members with regular and constructive performance feedback, encourage sharing better 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 of 10+ years relevant Pharmacovigilance/Pharmaceutical Industry experience; Demonstrated ability to mentor and coach others
Key Competency Requirements
Leads/manages a team or complex scope of work to ensure high quality delivery of pharmacovigilance activities.
Ability to effectively lead a team and work well within cross-functional teams, using strong organizational, facilitation, and interpersonal communication skills.
Defines and standardizes best practices and development opportunities for the scientist team
Builds a collaborative, supportive learning environment
Provides timely information to drive accurate decision making and ability to make good decisions based upon a mixture of analysis, knowledge, experience, and judgment.
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)
Effective time management and comfortably handles risk and uncertainty.
Ability to handle conflict and reads situations quickly; good at focused listening and finds common ground achieving cooperation and resolution.
Personally committed to improve self; open to coaching and feedback to improve PV Science Team.
Knowledgeable about how organizations work, the proper channels to get things done, understands the culture and BMS Core Behaviors.
Hires the best talent from inside or outside the organization. Treats direct reports equitably; acts fairly, has candid discussions; Establishes clear direction. Is aware of direct report's career goals.
Provides challenging and stretching tasks. Distributes workload appropriately; brings out the best in people; clear communicator; pushes direct reports to accept developmental moves; is a people builder.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it 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.
BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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