Director, Global Medical Safety Lead

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

Job summary

Bristol Myers Squibb in Princeton, NJ, is seeking a Director of Medical Safety Assessment to lead global safety strategies for assigned compounds. You will oversee DSURs, PBRERs, safety reviews, and regulatory submissions, while acting as the Safety SME for labeling and cross-functional teams.

The role requires MD or equivalent, 3+ years in pharmacovigilance, and proven leadership in a complex matrix environment. You will mentor colleagues and drive process improvements, with travel as needed.

Qualifications

• MD or equivalent required, with postgraduate qualification in medicine or related field.
• 3+ years in PV or a relevant pharma/biomedical field is strongly preferred.

Responsibilities

• Lead safety activities and benefit-risk strategies for assigned BMS compounds and chair the product SMT(s).
• Oversee, prepare, and review aggregate safety review documents and safety sections of regulatory filings.
• Lead evaluation and management of safety signals from any data source and document outcomes.
• Lead safety labeling activities and act as Safety SME for regulatory labeling input and cross-functional meetings.
• Support EU QPPV or other regional PV roles for assigned products.
• Contribute safety input to R&D publications and presentations.

Skills

PV knowledge

Regulatory understanding

Analytical reasoning

Communication skills

Multi-project capability

Team leadership

Attention to detail

Education

MD or equivalent

Job description

Bristol Myers Squibb in Princeton, NJ, is seeking a Director of Medical Safety Assessment to lead global safety strategies for assigned compounds. You will oversee DSURs, PBRERs, safety reviews, and regulatory submissions, while acting as the Safety SME for labeling and cross-functional teams.

The role requires MD or equivalent, 3+ years in pharmacovigilance, and proven leadership in a complex matrix environment. You will mentor colleagues and drive process improvements, with travel as needed.