Director, Global Risk Management, Cardiovascular
vor 7 Monaten
**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.
**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.
**Summary**
The Global Risk Management Therapeutic Area reports to the GRM Therapeutic Area (TA) Lead.
This critical role supports the development and effective implementation of Risk Management Plans (RMPs) for assigned assets by 1) leading the development of the Company Core Risk Management Strategy (CCRMS), the Global, European Union (EU) and Local Market (LM) RMPs, 2) driving implementation activities and 3) providing authoritative expertise and support for all local markets. This role may have supervisory responsibilities as line manager for the GRM TA function, provide risk management expertise for additional developmental and/or marketed products assigned by the TA Lead and have accountabilities for other key GRM TA projects and processes.
**Responsibilities**
- Provide strategic leadership regarding the development and implementation of RMPs and activities including additional risk minimization measures (ARMM), and additional pharmacovigilance activities (APVA)
- Provide for connection between the Safety Management Team (SMT) and the International LM Patient Safety (PS) team in developing and implementing RMPs and activities
- Serve as senior reviewer on Global RMP and EU RMP authoring teams
- Support ARMM development as per CCRMS or Health Authority (HA) requirement
- Support protocol development (including senior review) for Non-Interventional Research (NIR) protocols (both for local market and regional areas) that are APVA, including evaluations of effectiveness of risk minimization programs
- Provide risk management expertise for additional developmental and/or marketed products assigned by the TA Lead
- Support the GRM TA Leadership team regarding strategic priorities and in developing the GRM TA team culture
- Collaborates with other functional groups to ensure timely publishing of RMP documents, maintain inspection readiness and develop risk management-related metrics
- Participate in audits and inspections related to risk management
- Guides the development of GRM TA processes and procedures working in conjunction with the Global Process Lead (GPL)/Global Process Owner (GPO)
- Represent GRM interests, as requested, in external groups (e.g., pharmaceutical industry trade associations)
- Cultivates and maintains external relationships with leading GRM experts and companies
- Maintains a thorough understanding of RM regulations, and industry trends
- Other responsibilities as assigned by GRM TA Lead
**Requirements**:
- Bachelor’s degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.)
- More than 10 years of relevant pharmaceutical industry experience
- Experience in global pharmaceutical safety risk management is required
- Management experience is preferred
- Thorough understanding of GRM regulations and pharmacovigilance/regulatory environment is expected
**Skills/Knowledge Required**:
- Demonstrated effective leadership capability and ability to work across a matrix organization
- Ability to lead decision-making processes involving multiple cross-functional stakeholders
- Proven ability to lead and foster partnerships within a functional area, across organizational boundaries and companies (vendors/licensing partners)
- Creative thinker, exceptional listening and analytical skills, along with excellent written, verbal and interpersonal communication skills
- Demonstrated skills in problem solving, including in challenging and ambiguous situations
- Demonstrated ability to drive change and respond to changing environment
- Advanced user of Microsoft Office tools
- Minimal travel required
**Uniquely Interesting Work, Life-changing Careers**
**On-site Protocol**
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, empl
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