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Job Details


Bristol-Meyers Squibb, Co.

Associate Director, Global Risk Management (R1545479-en-us-3)

Pharmaceuticals

All

Yearly

No

Summit, New Jersey, United States

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.

Description

The Global Risk Management (GRM) Associate Director, reports to the GRM Lead, for the Therapeutic Area (TA) Immunology, CV, Fibrosis and Mature Products. 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, Immunology, CV, Fibrosis and Mature Products.

Responsibilities

  • Accountable for global development and implementation of RMPs and activities, including by serving as the key bridge between the Safety Management Team (SMT) and International Worldwide Patient Safety (WWPS) Team.

  • Leads the development of RMPs as core team reviewer, including any additional risk minimization measures (aRMM) and additional pharmacovigilance (PV) activities (APVA).

  • Manages the strategic development and update of Global/EU educational materials that are aRMM in conjunction with GRM Lead Immunology, CV, Fibrosis and Mature Products, SMT Chair, Headquarters (HQ) Medical, and Global Regulatory Team Lead (GRTL).

  • Leads product-centered RMP cross-functional Implementation Teams for those products with aRMM.

  • Provides guidance and support to LM PV during development of and when implementing RMP, aRMM and APVA Global/Regional (eg, EEA), and/or local commitments.

  • Collaborates with GRM Lead, Immunology, CV, Fibrosis and Mature Products 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, supports LM PV with development as needed.

  • Expert contributor to Health Authority (HA) responses arising from Rapid Response Teams (RRTs) for HA queries, ensuring alignment with the BMS Company risk management position and strategy. Supports LM PV to address RMP-related queries from Local HA

  • Supports aggregate report (eg, DSUR, PBRER/PSUR) preparation, as needed.

  • Liaises with GRM Publishing regarding the planned schedule of LM RMP and RMP-related documents (eg, Country-Specific Annex/Addendum, LM RMP Summary, Implementation Reports).

  • Supports GRM Publishing in their development, implementation, and optimization of RMP tracking and activity tools, eg, Regulatory Information Management System (Verity), RMP Tracker, Local Market Implementation Tracker (LMIT), aRMM/APVA Book of Work, and GRM SharePoint.

  • Supports preparation of meeting materials and participates in SMT Meetings and the Risk Management Strategy Committee (RMSC) as directed by GRM Lead, Immunology, CV, Fibrosis and Mature Products.

  • Participates in International PV Meetings as directed by GRM Lead, Immunology, CV, Fibrosis and Mature Products.

  • Supports Regional WWPS Leads as directed by GRM Lead, Immunology, CV, Fibrosis and Mature Products.

  • Supports GRM Center of Excellence regarding procedural document updates and maintenance of inspection readiness, and provides RMP-related metrics as requested

  • Maintains a thorough understanding of GRM regulations and industry trends regarding the implementation of GRM.

  • Other responsibilities as assigned.

Requirements:

  • BS/BA required, advanced degree in healthcare science, public health, or applicable fields, preferred

  • More than 7 years of pharmaceutical, clinical or relevant healthcare industry experience

  • Experience in global pharmaceutical risk management required

  • Thorough understanding of pharmacovigilance/regulatory environment is expected

  • Thorough understanding of GRM regulations

Skills/Knowledge Required:

  • Proven ability to foster partnerships across companies and organizational boundaries.

  • Demonstrated ability to lead cross-functional teams, work independently, and drive decisions that involve multiple constituencies and constraints.

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

  • Advanced user of Microsoft Office tools.

  • Occasional travel required (5%)

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 . Visit[Register to View] target="_blank"> [Register to View] 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.