Senior Manager, GRM TA, Global Risk Management
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 post-marketing commitments, and ensuring compliance with global regulatory requirements.
The Global Risk Management (GRM) Senior Manager, reports to the GRM Lead, for the Hematology. This role is focused on supporting and leading the development of Global, EU, and Local Market (LM) Risk Management Plans (RMPs) and driving LM implementation activities for specific products as directed by the GRM Lead.
Support the GRM Lead with developing and implementing RMPs and activities by serving as a bridge between the Safety Management Team (SMT) and International Worldwide Patient Safety (WWPS) Team as appropriate
Assist in the development of therapeutic area RMPs, including any additional risk minimization measures (aRMM), educational materials, and additional pharmacovigilance (PV) activities (APVA) in conjunction with GRM Lead TA, SMT Chair, Headquarters (HQ) Medical, and Global Regulatory Team Lead (GRTL)
Serve as contributing reviewer on Global RMP and EU RMP authoring teams for therapeutic area
Assist in product-centered RMP cross-functional Implementation Teams for those products with Health Authority (HA)-mandated aRMM
Support LM during development of and when implementing RMP, aRMM and APVA Global/Regional (e.g., EEA), and/or local commitments
May collaborate with GRM Lead in protocol development for Non-Interventional Research (NIR) protocols for Post-Authorization Safety Studies (PASS), including evaluations of effectiveness of risk minimization and APVA or programs (Global and EU). For LM protocols, support LM PV with development as needed
Support LM to address RMP-related queries from Local HA
Contribute to HA responses arising from Rapid Response Teams (RRTs) for HA queries, ensuring alignment with the BMS Company risk management position and strategy
Liaise with GRM Publishing regarding the planned schedule of LM RMP and RMP-related documents (e.g., Country-Specific Annex/Addendum, LM RMP Summary, Implementation Reports)
Support development, implementation, and optimization of RMP tracking and activity tools, e.g., RMP Tracker/Verity, Local Market Implementation Tracker (LMIT), ARMA/APVA Book of Work, and GRM SharePoint
May participate in the Risk Management Strategy Committee (RMSC) as directed by GRM Lead TA. Participate in International PV Meetings as directed by GRM Lead TA
May support GRM Center of Excellence regarding procedural document updates and maintenance of inspection readiness, and provide RMP-related metrics as requested
Maintain a thorough understanding of GRM regulations, and industry trends regarding the implementation of GRM
Support aggregate report preparation, as needed
Other responsibilities as assigned
Experience / Degree Requirements:
Bachelor’s degree required. Advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.)
More than 5 years of pharmaceutical, clinical or relevant healthcare industry experience
Experience in global pharmaceutical risk management required
Understanding of pharmacovigilance/regulatory environment is expected
Proven ability to foster partnerships across companies and organizational boundaries
Demonstrated ability working in cross-functional teams, and driving decisions that involve multiple constituencies and constraints
Excellent listening and analytical skills, along with excellent written, verbal and interpersonal communication skills
Thorough understanding of GRM regulations
Proficient user of Microsoft Office tools
Occasional travel required
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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