Bristol-Myers Squibb Company

Medical Safety Assessment Physician

Location
Princeton, NJ, United States
Posted
Oct 04, 2019
Ref
R1518126
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.

Job Description Summary
  • Establish and chair the Safety Management Team (SMT; formerly known as Medical Surveillance Teas [MST]) for assigned products
  • Conduct proactive Signal Detection activities
  • In the area of Signal Detection/Safety Surveillance, evaluate and integrate data from multiple sources, including clinical, non-clinical and real-world, to understand and manage safety signals
  • Collaborate with non-clinical and clinical discovery/clinical research/medical affairs colleagues to review protocols and study reports and contribute to proactive planning of all studies related to safety assessments
  • Make labeling recommendations based on proactive signal detection and signal assessment activities
  • Accountable for Risk Strategy, Risk Assessment, and Risk Minimization for BMS products in partnership with other BMS functions
  • Serve as Safety Consultant for product development activities
  • Leader or key contributor to safety data queries/Health Authority Responses
  • Medical Safety Lead for aggregate safety reports and strategic documents
  • Provide medical evaluation of aggregate safety data, 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 and BMS cost effectiveness goals
  • Promote collegiality and teamwork among peers and mentor/support colleagues in department as a positive change agent


Description
  • Leads Safety Management Team (SMT; formerly known as Medical Surveillance Teas [MST]) for assigned products
  • In the area of Signal Detection/Safety Surveillance, evaluate and integrate data from multiple sources, including clinical, non-clinical and real-world to understand and manage safety signals
  • Accountable for Risk Strategy, Risk Assessment, and Risk Minimization for BMS products in partnership with other BMS functions
  • Serve as a Safety Consultant for product development activities
  • Leader or key contributor to safety data queries/Health Authority Responses
  • Medical Safety Lead for aggregate safety reports and strategic documents
  • Serve as a trusted partner to other R&D functions in representing the view on product safety, and lead in a matrix environment through scientific competency and organizational influence and impact.
  • Contributes to departmental and cross-functional improvement initiatives


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, oncology, or related specialty is desirable
  • Other relevant experiences and accomplishments will be considered, such as roles in clinical research, observational research, and clinical practice experience


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 product
  • 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
  • Excellent 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.