Bristol Myers Squibb Associate Director, Risk Management Strategy & Implementation Lead in Pennington, New Jersey
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
Purpose/Objective of the job
This Associate Director, Risk Management Strategy & Implementation Lead will lead the development and effective implementation of risk management strategy for BMS’s exciting IO (immune Oncology) products across the world in alignment with complex Health Authority requirements prior to commercialization of IO products
This position is highly visible within the organization; reports to Director, Risk Management Strategy for Immuno-Oncology (GSRM IL-IO), contributes to, and/or supports GSRM Business Updates for GPV&E Senior Management and actively participates in International PV and other GPVE Meetings, as required
The role will work with matrix partners in Medical, PV, Commercial & Safety to effectively facilitate development of Risk Management Plans (RMPs) and support/oversee implementation in local market plans by providing authoritative expertise
Will play a critical role in developing innovative tools to communicate/educate Healthcare professional & patients on safe and effective use of BMS’s IO products.
This Associate Director, Risk Management Strategy & Implementation Lead will facilitate RMP development and Implementation activities, providing authoritative expertise and support for International markets excluding the United States (US) and Japan (JP), and may also provide support to the GSRM Document Manager for development of local market (LM) RMP and RMP-related documents when dictated by business needs.
May act as delegate or back-up for any other Risk Management Strategy & Implementation Lead, as required.
Key Responsibilities and Major Duties
Serve as subject matter expert for assigned product RMPs including any additional risk minimization activities (ARMA, also called ARMM, additional risk minimization measures) and additional PV activities (APVA)
Support and review LM RMPs and ARMA as necessary.
Support LM when implementing ARMA and APVA Global/Regional (eg, EEA), and/or local commitments
Participate 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.
Develop and provide RMP related metrics to stakeholders as dictated by business needsWork closely with the Regional PV Leads to identify the PV resources needed to implement RMP commitments in LM
Support LM to address RMP-related queries from local HA. Collate experience and lessons learned to develop best practice
Actively contribute to Rapid Response Teams (RRTs) to respond to HA questions, ensuring alignment with the BMS Company position and strategy. If required, lead and/or coordinate the development of responses for RMP related questions in collaboration with the MST Chair, Document Manager, and other stakeholders.
Provide guidance and support to the GSRM Document Managers for development of LM RMP and RMP-related documents (eg, LM RMP, RMP Annex/Addendum, LM RMP Summary, Implementation Reports)
As required, contribute to and support the development, implementation, and optimization of GSRM RMP tracking and activity tools, eg, RMP Tracker/Verity, Local Market Implementation tracker (LMIT), ARMA/APVA Book of Work (BOW).
Lead, contribute to, and/or support procedural document updates (eg, GSRM Best Practice, GSRM Job Aids, International PV Manual [IPVM] updates) as required.
Lead, contribute to, and/or support GSRM Business Updates for GPV&E Senior Management.
Actively participate in International PV and other GPVE Meetings, as required.
Ensure inspection readiness (including updates of Pharmacovigilance System Master File [PSMF]) and that any audit/inspection findings are addressed adequately for GSRM.
Propose creative solutions for continuous improvement to LM processes and or/core activities.
Support the Head of GSRM in driving the wider Risk Management agenda by engaging with key stakeholders, including LM and Headquarters (HQ).
Support External Affairs to ensure that Pharmacovigilance Agreements (PVA) align with GSRM strategy.
Participate on Global, EU, and US RMP authoring teams as appropriate.
List of minimum requirements:
• Degree/Certification/Licensure: Life Science degree
Responsibility and minimum number of years: Substantial experience in a medical/scientific function in BioPharma (eg, at least 5 years in PV, Medical, Regulatory
Understanding of PV/Regulatory environment
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.