Senior Director, Safety Science & Pharmacovigilance

Bristol-Myers Squibb Company; New Jersey; On-site; USD 307,000 - 372,000; Full time

Benefits offered by this job

Flexible Time Off

11 holidays per year

Vacation time

Job summary

RayzeBio, a wholly‑owned subsidiary of Bristol Myers Squibb, seeks a Safety MD to lead global pharmacovigilance across clinical development and post‑marketing activities from its New Jersey operations.

You will drive proactive safety surveillance, signal detection, risk management, and benefit‑risk assessment, mentor cross‑functional teams, and collaborate with regulatory authorities to ensure patient safety.

Qualifications

• MD or equivalent degree.
• 10+ years pharmacovigilance experience.
• Experience with FDA, EMA, ICH regulations.
• Radiopharmaceutical/oncology safety experience preferred.

Responsibilities

• Lead global pharmacovigilance strategy and proactive safety surveillance.
• Establish safety governance structures and SOPs.
• Partner with safety, clinical development, regulatory, medical affairs, and cross‑functional teams to integrate safety insights.
• Direct safety evaluation and benefit‑risk assessment for clinical and post‑marketing products.
• Represent Safety Science as lead or co‑lead in Safety Management Teams/Committees and regulatory interactions.
• Drive safety‑related content for protocols, DSURs, PSURs, RMPs, CSRs, and regulatory responses.
• Perform daily ICSR/SAE case reviews across all trial phases.
• Mentor cross‑functional colleagues on PV concepts and practices.
• Leverage AI to improve program performance and outcomes.

Skills

Leadership

Communication

Cross-functional collaboration

Patient safety

Travel

Education

MD or equivalent

Job description

RayzeBio, a wholly‑owned subsidiary of Bristol Myers Squibb, seeks a Safety MD to lead global pharmacovigilance across clinical development and post‑marketing activities from its New Jersey operations.

You will drive proactive safety surveillance, signal detection, risk management, and benefit‑risk assessment, mentor cross‑functional teams, and collaborate with regulatory authorities to ensure patient safety.