Medical Director Medical Safety Assessment Immunology

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary

The Medical Safety Assessment Physician (MSAP) serves as the BMS expert on all aspects of medical drug safety for assigned products in the BMS portfolio. The MSAP chairs the cross-functional Safety Management Team, which is established to ensure strategic, proactive assessment of BMS product safety throughout the product life cycle. The MSAP works closely with partners within the patient safety department and the broad BMS organization. He/she will work on products within the immunology therapeutic area, in support of a rapidly growing portfolio of products.

Responsibilities


Establish and chair the Safety Management Team for assigned products in the immunology therapeutic area
Conduct proactive signal detection activities
Evaluate and integrate data from multiple sources, including clinical, nonclinical and real world, to understand safety signals
Characterize safety concerns to support risk assessment
Be accountable for risk strategy, risk assessment, and risk minimization for assigned products in partnership with other BMS functions
Make labeling recommendations based on proactive signal detection and signal assessment activities
Collaborate with colleagues to review protocols and study reports and contribute to proactive planning of all studies related to safety assessments
Serve as a safety consultant for product development activities
Lead or act as a key contributor to safety data queries/Health Authority responses
Serve as the medical safety lead for aggregate safety reports and strategic documents; provide medical evaluation of aggregate safety data and develop and write medical sections of periodic and ad hoc safety reports
Develop and implement risk management plans (RMPs) for assigned products according to the most current regulatory guidelines
Make senior-level presentations as requested
Support departmental strategic initiatives
Provide a medical perspective into departmental standards and support process improvement initiatives as needed
Ensure that the above tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements
Serve as a trusted partner to other functions in representing the view on product safety
Lead in a matrix environment through scientific competency and organizational influence and impact
Promote collegiality and teamwork among peers and mentor/support colleagues in the department as a positive change agent


Background/Experience


A Medical Degree (MD or equivalent) is required
A doctoral degree and/or MPH is desirable
At least 3 years in pharmacovigilance or relevant pharmaceutical or biomedical field is strongly preferred
Postgraduate qualification or experience in immunology or related specialty is desirable
Other relevant experiences and accomplishments will be considered, such as roles in clinical research, observational research, and clinical practice


Competencies/Knowledge/Skills


Understanding of the drug development process
Knowledge of pharmacovigilance and ability to apply knowledgeto evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug
Ability to leverage the range of available tools to investigate safety concerns, including the science of observational research
Understanding of regulatory requirements for safety assessment and action
Strong scientific analytical reasoning skills
Ability to work on multiple complex projects in parallel
Exceptional attention to detail
Behavioral competencies necessary to work and lead within a complex matrix environment
Excellent verbal and written communication skills


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.

Company: Bristol-Myers Squibb

Req Number: R1521454_EN

Updated: 2020-02-04 00:00:00.000 UTC

Location: Princeton,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.

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