Senior Pharmacovigilance Scientist - Safety Signals Lead

Bristol Myers Squibb; Princeton (NJ); Hybrid; USD 146,000 - 177,000; Full time

Job summary

Bristol Myers Squibb is seeking a Senior Manager, Pharmacovigilance Scientist in New Jersey to independently perform core signal detection activities and lead safety data review meetings. You will evaluate and mitigate risks, ensure pharmacovigilance regulatory compliance, and support regulatory submissions and labeling updates.

The role emphasizes collaboration with SMT, MSAP/SAFETY teams and cross-functional partners to drive safety strategy and risk management across product life cycles.

Qualifications

• Scientific degree (BS, MS, RN, PharmD, PhD, MD) or other degree with relevant education and experience.
• Minimum of 4-6 years of pharmacovigilance/pharmaceutical industry/drug development experience.
• Working understanding of medical concepts and safety activities in drug development and global health authority requirements.
• Ability to manage timelines, priorities and quality with cross-functional collaboration.
• Adaptable, detail-oriented with strong analytical and scientific skills.

Responsibilities

• Performs core signal detection and assessment activities across the product life cycle, contributing to safety assessments with increasing autonomy.
• Leads safety data review meetings and escalates issues impacting SMT activities and milestones.
• Writes safety and risk management sections of DSUR, PBRER, PADER and other regulatory documents with oversight.
• Supports safety strategy in regulatory filings and labeling updates as needed.
• Assists in communication with health authorities and local markets on risk management matters.

Job description

Bristol Myers Squibb is seeking a Senior Manager, Pharmacovigilance Scientist in New Jersey to independently perform core signal detection activities and lead safety data review meetings. You will evaluate and mitigate risks, ensure pharmacovigilance regulatory compliance, and support regulatory submissions and labeling updates.

The role emphasizes collaboration with SMT, MSAP/SAFETY teams and cross-functional partners to drive safety strategy and risk management across product life cycles.