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
Associate Director, Medical Safety Review provides high quality medical review of ICSRs including the determination of regulatory reportability of clinical trial cases and certain spontaneous reports. Associate Director, Medical Safety Review performs signal detection based on ICSRs and discusses with relevant stakeholders for further action.
Medical Review: 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 if applicable.
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. Demonstrated ability to apply BMS operating philosophy and operate within company policies and procedures and appropriate regulations.
Collaboration: Partner with WWPS personnel from other functions (AE processors, PV Scientists, ESR safety scientists and Medical Safety Assessment Physicians) in evaluating the safety profile of BMS compounds of responsibility. Identifies potential safety signals and informs the appropriate safety assessment physician 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 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)
Education Required: MD or Equivalent. Board certification and medical specialty preferred.
Minimum 2-4 years in clinical practice or relevant setting.
Minimum 1-3 years in pharmaceutical industry (clinical research, pharmacovigilance 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.
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. 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 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.
Company: Bristol Myers Squibb
Req Number: R1534035-en-us-1
Updated: 2021-01-06 01:07:22.947 UTC
Location: Summit,New Jersey
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.