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.

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 Associate Director, Medical Safety Review provides high quality medical review of ICSRs including the determination of regulatory reportability of clinical trial cases and certain post-marketing reports. The Associate Director, Medical Safety Review supports signal detection and risk management-related activities.

Position Responsibilities

• Medical Review: 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.  Provides oversight of single case processing vendor re: medical review for products of responsibility if applicable.  Leads Case Processing & Review meetings for assigned products. Supports signal detection and risk management requirements globally for assigned products throughout the product life-cycle. Executes RMP re: ICSR/medical review-related PV activities. Ensures special health authority requirements are met pertaining to medical assessment and submission of ICSRs.

• Compliance: Ensures complete and timely reporting of medical cases to regulatory authorities globally for products of responsibility. Implements quality and compliance controls pertaining to medical review of ICSRs. Collaborates with QST to ensure consistency of work practices and SOPs. Applies BMS operating philosophy and operates within company policies and procedures and appropriate regulations.

• Collaboration: Partner with WWPS personnel from other functions (AE processors, PV Scientists, ESR safety scientists, CS3 and Medical Safety Assessment Physicians (MSAPs) in evaluating the safety profile of BMS compounds of responsibility. Ad hoc member of SMT. Identifies potential safety signals and informs the MSAP of all potentially important cases and issues.

• Development/Processes: Identifies safety-related issues and escalates them to MR TA Head and MSAP as needed. Deals with safety-related issues using critical medical and regulatory analytical strategies to develop optimal solutions. Is an active, high energy proponent of the Company’s commitment to public health. Influences and impacts others through clear reasoned argument, helps to drive consensus of opinion, and catalyzes action to meet critical regulatory objectives. Represents WWPS within areas of responsibility and 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 / Experience Requirements

• Required: MD or Equivalent. Board certification and medical specialty is preferred.

• Minimum 2-4 years in clinical practice or relevant setting.

• Minimum 1-3 years in pharmaceutical industry (pharmacovigilance, clinical research or medical affairs) or equivalent.

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, helps to drive consensus of opinion, and catalyzes action to meet critical regulatory objectives.

• Demonstrated creative 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, interpersonal and time management skills

• Demonstrated flexibility, open mindedness and adaptability in a rapidly changing environment.

• Ability to build and manage inter-relationships by motivating and inspiring others. 

• Ability to operate with minimal direction.

• 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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