Therapeutic Area Head (Director), Medical Safety Review, Oncology

Company: Bristol-Myers Squibb
Location: Princeton
Posted on: February 25, 2021

Job Description:

Therapeutic Area Head (Director), Medical Safety Review, Oncology Princeton - NJ - US 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. Summary: The TA Head - Medical Safety Review provides oversight of all products within the therapeutic area, manages and develops the Medical Review Safety Physicians (MRSPs) within the therapeutic area. May have own product responsibilities for which provides high quality medical review of ICSRs including the determination of regulatory reportability of clinical trial cases and spontaneous reports. Performs signal detection based on ICSRs and discusses with relevant stakeholders for further action. Represents MR in cross-functional meetings and makes informed decisions within the area of expertise. If applicable, provides oversight of MR of assigned TA at the ICSR Processing offshore vendor. Position Responsibilities Management: Provides oversight of all products within the designated therapeutic area; 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: For products within the assigned TA, provides medical review of individual serious spontaneous reports of adverse events. Provides medical review and performs causality assessment and determines regulatory reportability of clinical trial cases for assigned products and across therapeutic areas. Provides oversight of single case processing vendor re: medical review for products of responsibility. As applicable, leads all quality monitoring efforts related to medical review. Compliance: Ensures complete and timely reporting of medical cases to regulatory authorities globally for products of responsibility. Collaborate with QST to ensure consistency of work practices and SOPs. Demonstrates ability to apply BMS operating philosophy and operate within company policies and procedures and appropriate regulations. Collaboration: Partners with WWPS personnel (AE processors, PV scientists, ESR Scientists and Medical Safety Assessment Physicians) and personnel from other functions and external stakeholders as the point of contact on medical review-related topics, evaluating the safety profile of BMS compounds within the therapeutic are of responsibility. Identifies potential safety signals and informs the appropriate MSAP of all potentially important cases and issues.-- Development/Processes: 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, 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.) Qualifications Education Required: MD or Equivalent. Board certification and medical specialty preferred. 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. 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. Familiarity with applicable regulatory guidelines. Experience working in a team environment, including supporting other team members when necessary; promote collegiality and teamwork among peers. Ability 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. Creates, aligns and communicates clear objectives with organizational goal. Excellent oral, and written English skills.-- Excellent communication, interpersonal, people 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.-- 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. W e're creatinginnovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

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