Job Information
Bristol Myers Squibb Senior Director, Head of Medical Review in Madison, New Jersey
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us .
Functional Area Description
The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines. This includes all 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 safety post-marketing commitments and ensuring compliance with global regulatory requirements.
Position Summary / Objective
The Head of Medical Safety Review provides leadership and direction for a department of up to 80 in-house and vendor-employed Medical Safety Review Physicians and their Therapeutic Area Heads across all PVOpS sites. Develops departmental strategy for best practice in delivering excellence in the Medical Review (MR) of Adverse Event reports for all BMS development and marketed products. Represents MR in the PV Operations and Systems Leadership Team and the WWPS Extended Leadership Team. Provides MR expertise and makes informed MR decisions in cross-functional meetings on most critical ICSRs in order to protect patients, BMS products, and BMS regulatory compliance.
Position Responsibilities
Strategic: Decides Medical Review strategy with regard to driving continuous improvement and transformation of PV Operations into a highly automated, efficient organization dedicated to achieving industry-leading medical quality, compliance, and cost effectiveness. Builds Medical Review capabilities in all global PVOpS sites. Drives change-management in Medical Review regarding process innovation. Creates strategy and provides oversight of single case processing vendor regarding medical safety review of company cases across TAs.
Management: Manages and develops the Therapeutic Area Heads / Directors within Medical Safety Review. Takes the global lead in assuring consistent application of work practices and processes. Delegates to and develops TA Heads / Directors to ensure talent retention and succession planning. Encourages development and empowerment of Medical Review Safety Physicians (MRSPs) to the best of their abilities.
Medical Review:
Provides guidance regarding medical review of individual clinical trial and post-marketing reports. Oversees single case processing vendor regarding medical review strategy and structure. Ensures Medical Safety Review Physicians identify potential single case safety signals and other potentially critical cases and issues.
Compliance: Accountable for compliance relating to complete and timely assessment of ICSRs for all BMS products for submission per local regulatory requirements. Oversees MR QM effort and collaborates with QST to ensure consistency of work practices and SOPs. Represents or delegates MR representation at audits and inspections; writes CAPA and oversees CAPA execution. Applies BMS operating philosophy and operate within company policies and procedures and appropriate regulations.
Oversees execution of RMP re: ICSR-related PV activities. Oversees HA-commitment review and execution pertaining to ICSR assessment.
Process:
Ensures high quality approach to medical assessment of ICSRs with particular attention to defining critical cases (e.g. SUSARs, AEs of Interest, potential Drug-Induced Liver Injury [DILI], pregnancy, product specific critical events). Final decision contact as needed for seriousness, causality and expectedness assessment of sincle adverse event cases. Provides input the development of the Reference Safety Information section of the Investigator's Brochure; provides peer review for safety documents (RMP, IB, aggregate reports, labels for marketed products).
Collaboration: Partners with WWPS personnel at similar leadership level (Head of Case Management, Head of PVOpS OpEx, Head of PVOpS Data Acquisition and Interfaces, PV Scientist Leads, and SMT Chairs, MSA TA Heads) and executives from other functions and external stakeholders. Contributes to the evaluation the safety profile of BMS compounds. Ad hoc member of SMT. Ensures identification of potential safety signals by MRSPs from individual case reports and informs / delegates information of the appropriate SMT Chair / MSA TA Head of all potentially important cases and issues. Leads Medical Review vendor quality monitoring, training and oversight for the therapeutic area.
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, and catalyzes action to meet critical regulatory objectives. Represents PVOpS and MR within areas of responsibility, competence and experience. drives process improvement and automation opportunities and 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)
Experience / Degree Requirements
Education required: MD or Equivalent. Board certification and medical specialty relevant to BMS product portfolio preferred.
Minimum of 7 years combined relevant experience, including at least 2 years in clinical practice or relevant setting and at least 5 years of pharmaceutical industry experience including management experience. Global matrix organization leadership experience and vendor management experience strongly preferred.
Key Competency Requirements
Knowledgeable and skilled in medicine and pharmaceutical product safety with a track record of working in pharmacovigilance
Knowledgeable of ICH Guidelines and relevant US and EU PV and GCP regulations. Able to interpret regulations and create new processes as needed.
Experience applying medical knowledge to the interpretation of individual case review; strong skills in differential medical diagnosis.
Working in a global corporate business context.
Experienced in using MedDRA and WHODrug.
People management experience mandatory.
Ability to develop and present independent, reasoned solutions to identified safety issues, 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.
Experience working in a team environment, including supporting other team members when necessary; promoting collegiality and teamwork among peers.
Experience with a major safety database (e.g. Oracle ARGUS or ArisG).
Travel Required:
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1587478
Updated: 2024-11-30 05:20:19.286 UTC
Location: Princeton-NJ
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.