Job Description

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.

The Global Risk Management Lead, and is based in either Summit NJ, Princeton NJ, Uxbridge UK, or Boudry.

This critical role supports the development and effective implementation of Risk Management Plans (RMP) for a therapeutic area by; (1) facilitating the Global, EU, and local market (LM) RMP development and implementation activities, (2) providing authoritative expertise and support for all markets, and (3) driving LM implementation activities for product assignments as directed by the GRM Head.

Responsibilities

• Serve as a bridge between the Safety Management Team (SMT) and the International WWPS Team in developing and implementing risk management plans and activities

• Support the GRM Head in driving the wider Risk Management agenda by engaging with key stakeholders, including LM and Headquarters (HQ)

• Serve as senior reviewer on Global RMP and EU RMP authoring teams for therapeutic area

• Lead project teams to ensure implementation of departmental enhancements and goals

• Provide subject matter expertise for therapeutic area product RMPs, including any additional risk minimization activities (ARMM) and additional pharmacovigilance (PV) activities (APVA)

• Lead and supervise product-centered RMP cross-functional Implementation Teams for those products with HA-mandated ARMA

• Develop and update Global educational materials that are ARMA in conjunction with SMT Chair, Headquarters (HQ) Medical, and Global Regulatory Team Lead (GRTL)

• Support and review LM 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.

• Collaborate with GRM Center of Excellence to develop and provide RMP related metrics to stakeholders as dictated by business needs

• Collaborate with the Regional WWPS Leads to identify the WWPS 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 SMT Chair, Document Manager, and other stakeholders.

• Provide guidance and support to the GSRM Document Manager for development of LM RMP and RMP-related documents (eg, LM RMP, RMP Annex/Addendum, LM RMP Summary, Implementation Reports)

• Provide guidance to the GRM Publishing to support the development, implementation, and optimization of RMP tracking and activity tools, eg, RMP Tracker/Verity, Local Market Implementation tracker (LMIT), ARMA/APVA Book of Work (BOW), and GRM SharePoint.

• Actively participate in the Risk Management Strategy Committee (RMSC)

• Actively participate in International PV Meetings, as required

• Collaborate with GRM Center of Excellence regarding procedural document updates

• Collaborate with GRM Center of Excellence to maintain inspection readiness

• Maintain a thorough understanding of GRM regulations, and industry trends regarding the implementation of GRM

• Other responsibilities as assigned

Requirements:

• Bachelor’s degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.)

  10 years of Health Care industry experience, with 3-5 years of risk management experience is preferred.

• Management experience is preferred

• Understanding of pharmacovigilance/regulatory environment is expected

Skills/Knowledge Required:

• Exemplary leadership skills with proven ability to foster partnerships across companies and organizational boundaries

• Demonstrated effective leadership skills in building high performance teams, particularly across a matrix organization, and ability to lead decision-making processes that involve multiple constituencies and constraints

• Creative thinker, exceptional listening and analytical skills, along with excellent written, verbal and interpersonal communication skills

• Thorough understanding of GRM regulations

• Advanced 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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.