Bristol Myers Squibb

Senior Director, Therapeutic Area Lead, Medical Safety Review, Oncology

1 month agoPrinceton, NJ

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 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.

Position Summary / Objective

The TA Lead, Medical Safety Review provides oversight of all products within the assigned therapeutic area. Manages and develops the Medical Review Safety Physicians (MRSPs) within the therapeutic area. Represents MR in cross-functional meetings and makes informed decisions within the area of expertise. Provides oversight of MR of assigned TA for the ICSR Processing offshore vendor.

Position Responsibilities

  • Management: Manages and develops the Medical Review Safety Physicians (MRSPs) within the therapeutic area. Provides training and act as mentor to Medical Directors and Associate Medical Directors. Takes the lead in convening teams to assure consistent application of work practices and processes.
  • Medical Review: Subject Matter Expert (SME) for products within the assigned TA, provides medical review oversight of ICSRs. Creates strategy and provides oversight of single case processing vendor re: medical review for TA products. Leads Case Processing & Review Meetings for TA. Oversees execution of RMP re: ICSR-related PV activities. Involved in HA-commitment review and execution pertaining to ICSR assessment and reporting. For products within the assigned TA, provides medical review of individual serious spontaneous reports of adverse events. Provides high quality medical assessment of ICSRs with particular attention to critical cases (SUSARs, AEs of Interest, potential Drug-Induced Liver Injury [pDILI], pregnancy, any critical events). Provides seriousness, causality and expectedness assessment and determines regulatory reportability of ICSRs for assigned products.
  • Compliance: Ensures MRSPs meet/exceed expectations for compliance, quality, regulatory and safety initiatives. Leads all quality monitoring efforts related to TA product knowledge and medical assessment. Collaborates with QST to ensure consistency of work practices and SOPs. Applies BMS operating philosophy and operate within company policies and procedures and appropriate regulations.
  • Collaboration: Partners with WWPS personnel at similar leadership level (AE processor leads, PV scientist leads, ESR lead, and SMT Chairs, MSA TA Heads, CS3 lead) and personnel from other functions and external stakeholders. Serves as the medical review SME of assigned TA on cross-functional teams. Contributes to the evaluation the safety profile of BMS compounds within the therapeutic area of responsibility. Ad hoc member of SMT. Identifies potential safety signals and informs the appropriate SMT Chair / MSA TA Head of all potentially important cases and issues. Partners with Head of Medical Review Quality Monitoring, Training and Vendor Oversight re: training of MRSPs.
  • Development/Processes: Deals with safety-related issues using critical medical and regulatory analytical strategies to develop optimal solutions. Influences and impacts others through clear reasoned argument, helps to drive consensus of opinion, and catalyzes action to meet critical regulatory objectives. Represents MR within areas of responsibility, competence and experience. Ensures that the above tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and safety in accordance with company cost effectiveness goals.

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Degree Requirements
  • Education required: MD or Equivalent. Board certification and medical specialty relevant to the assigned TA preferred.

Experience Requirements
  • Minimum 2-4 years in clinical practice or relevant setting.
  • Minimum 5 years of pharmaceutical industry experience of which at least 3 year was dedicated to the medical evaluation and reporting of individual adverse events.
  • Management experience preferred.

Key Competency Requirements
  • Knowledgeable and skilled in medicine and pharmaceutical product safety.
  • Experience applying medical knowledge to the interpretation of individual case review; experience with reporting of individual adverse events.
  • Previous experience in the safety field and/or pharmaceutical industry preferred.
  • Experience working in a team environment, including supporting other team members when necessary; promoting collegiality and teamwork among peers.
  • Ability to think clearly and decisively and present independent, reasoned solutions to identified safety issues, support to drive consensus of opinion, and to catalyze action to meet critical regulatory objectives.
  • Demonstrated problem solving skills that enact change and drive continuous improvement.
  • Seeks to develop self and others. Aligns objectives with organizational goal.
  • Excellent oral, and written English skills.
  • Excellent communication, presentation, interpersonal and time management skills.
  • Demonstrated flexibility, open mindedness and adaptability in a rapidly changing environment.
  • Ability to build and manage interrelationships by motivating and inspiring others.
  • Ability to operate autonomously.
  • Experience in Argus or ArisG safety database is preferred.

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 to access our complete Equal Employment Opportunity statement.

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Job ID: BristonMyers-R1532336