Associate Director Medical Review
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
Purpose/Objective of the job:
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.
Key Responsibilities and Major Duties:
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.
Compliance: Ensures complete and timely reporting of ICSRs to regulatory authorities globally. 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 GPVE personnel from other functions (AE processors, safety scientists and safety assessment physicians) in evaluating the safety profile of BMS compounds. Identifies potential safety signals and informs the appropriate safety assessment physician of all potentially important cases and issues. Collaborates with other BMS colleagues to address safety concerns.
Development/Processes: Deals with safety-related issues using critical medical and regulatory analytical strategies to develop optimal solutions. Working closely with colleagues in QST to identify and implement new and more efficient processes for safety reporting and risk assessment. 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 GPVE 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)
- MD or Equivalent. Board certification and medical specialty
- 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.
Competencies - knowledge, skills, abilities, other
- 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.