Bristol-Myers Squibb Company

Medical Safety Assessment Physician

Location
Hopewell, NJ, US
Posted
Jul 18, 2018
Ref
R1508132
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.

  • Establish and chair the Medical Surveillance Teams (MSTs) for assigned products.
  • Develop and implement risk management plans for assigned products according to the most current regulatory guidelines.
  • Conduct proactive signal detection activities.
  • Make labeling recommendations based on proactive signal detection and signal assessment activities.
  • Make presentations as requested to senior medical review boards.
  • 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.
  • 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 safety consultant for product development activities.
  • Leader or key contributor to safety query 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 reports (PSURs, PADERs, ASRs) and ad hoc reports.
  • Supports 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 GPV&E as a positive change agent.


Responsibilities:
  • Leads all medical safety assessment and related activities for assigned molecules
  • Leads 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 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.


Degree/Certification/Licensure:

  • MD or Equivalent. Has completed a Board certification and/or relevant higher medical training.
  • Experience - Responsibility and minimum number of years-generally, has 3 or more years previous experience as medical safety assessment physician
  • Experience requirement may vary based on relevant experiences and accomplishments, such as:
    • Roles in pharmaceutical or biopharmaceutical industry
    • Clinical research
    • Observational research
    • Clinical practice experience
    • Medical educator
    • Medical administrator or
    • Medical quality assessment/improvement


Competencies - knowledge, skills, abilities, other
  • Clinical knowledge base as demonstrated by clinical practice experience, or comparable activity
  • Strong written and oral scientific communication skills
  • Strong scientific analytical reasoning skills
  • Behavioral competencies necessary to work and lead within 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
  • Understanding of regulatory requirements for safety assessment and action through 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.