Director, Medical Safety & Benefit-Risk Strategy

Bristol Myers Squibb; Princeton (NJ); On-site; USD 256,000 - 310,000; Full time

Job summary

Bristol Myers Squibb, based in New Jersey, seeks a Director, Medical Safety Assessment Physician to lead safety strategy for assigned compounds and chair product SMTs. You will oversee safety reviews and contribute to regulatory filings across global programs.

Ideal candidates have an MD with PV expertise and 3+ years in pharmacovigilance, with strong analytical and communication skills to drive cross-functional collaboration and safety improvements.

Qualifications

• MD/equivalent required; postgraduate qualification in internal medicine, immunology or oncology desirable.
• 3+ years in PV or relevant pharmaceutical/biomedical field strongly preferred.
• Experience with safety data, regulatory filings and cross-functional teams.

Responsibilities

• Lead safety activities and benefit-risk strategies for assigned BMS compounds and chair the product SMTs.
• Oversee, prepare, and/or review aggregate safety review documents and safety sections of trials and regulatory filings.
• Lead evaluation and management of safety signals; develop strategy for signal evaluation and document outcome.
• Lead safety labeling activities and provide input to regulatory labeling; participate in cross-functional labeling teams.

Skills

Drug development knowledge

Pharmacovigilance expertise

Analytical reasoning

Multitasking

Communication skills

Education

MD or equivalent

Postgraduate in internal medicine/immunology/oncology

Job description

Bristol Myers Squibb, based in New Jersey, seeks a Director, Medical Safety Assessment Physician to lead safety strategy for assigned compounds and chair product SMTs. You will oversee safety reviews and contribute to regulatory filings across global programs.

Ideal candidates have an MD with PV expertise and 3+ years in pharmacovigilance, with strong analytical and communication skills to drive cross-functional collaboration and safety improvements.