Medical Safety Assessment Physician

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

Leads and/or supports medical safety assessment and related activities for assigned molecules

Key Responsibilities and Major Duties

• Lead or support Medical Surveillance Teams,

• 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 assigned BMS products in partnership with other BMS functions.
• Serve as safety consultant for product development activities.
• Leader or key contributor to safety query 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 GPVE and cross functional improvement initiatives, as assigned

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

List of minimum requirements

• Degree/Certification/Licensure - Required: MD or Equivalent. Has completed a Board certification and/or relevant higher medical training.

• Experience - Generally , few years experience as a medical safety assessment physician

• If new to pharmacovigilance, generally has some other relevant experience such as:
  • Experience in pharmaceutical or biopharmaceutical industry
  • Clinical research
  • Observational research
  • Clinical care experience
  • Medical education
  • Medical administration
  • Medical quality assessment/improvement

• Competencies -

• Clinical knowledge base as demonstrated by clinical practice experience, or comparable activity
• Written and oral scientific communication skills
• Scientific analytic reasoning skills
• Behavioral competencies necessary for success in a complex matrix environment
• Understanding of drug development process, with knowledge of design and execution of randomized clinical trials
• Knowledge of pharmacovigilance and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product
• Sufficient understanding of regulatory requirements for safety assessment and action through the life cycle of a drug product.
• Understanding of the range of available tools to investigate safety concerns, including the science of observational research
• Software that must be used independently and without assistance (e.g., Microsoft Suite)