Medical Safety Assessment Physician Director

4 weeks ago


Madison, New Jersey, United States Bristol-Myers Squibb Full time
Job Summary

Bristol-Myers Squibb is seeking a highly skilled Medical Safety Assessment Physician Director to join our team. As a key member of our Worldwide Patient Safety group, you will be responsible for ensuring the safety of our medicines. Your expertise will be instrumental in leading safety activities and benefit-risk strategies for assigned BMS compounds/programs in the Immunology Therapeutic Area.

Key Responsibilities
  • Lead safety activities and benefit-risk strategies for assigned BMS compounds/programs in the Immunology Therapeutic Area.
  • Oversee, prepare, and/or review aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings.
  • Lead team in the evaluation & management of signals emerging from any data source.
  • Develop strategy for signal evaluation and document outcome.
  • Lead safety labeling activities for assigned products/program.
  • Act as the Safety Subject Matter Expert for input to regulatory product labeling.
  • Participate/provide input at cross-functional labeling team meetings and provide regional safety labeling support.
Requirements
  • MD/equivalent required.
  • Postgraduate qualification or experience in internal medicine, immunology, or related specialty desirable.
  • 3+ years in PV or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) is strongly preferred.
About Us

Bristol-Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. Our unique culture promotes diversity, inclusion, and innovation, and we offer a wide range of benefits and opportunities for growth and development.



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