Senior Manager, Patient Safety Scientist

Senior Manager, Patient Safety Scientist

Lead the essential pharmacovigilance activities that safeguard the safe use of Bristol Myers Squibb’s medicines throughout the product lifecycle. Work closely with Medical Safety Assessment Physicians, Safety Management Teams, and global regulators to detect signals, review data, and drive risk‑management strategies.

What You’ll Do

• Detect and manage safety signals through quantitative methods; author signal reports and flag issues that may influence safety milestones.
• Prepare and contribute to aggregate safety documents (DSURs, PBRERs, PADERs) and respond to regulatory authority inquiries.
• Support clinical development by integrating safety sections into protocols, investigator brochures, CSRs, and informed consent documents.
• Author safety content for regulatory submissions (MAAs, ISS, SCS) and product labeling (USPI, CCDS, SmPC).
• Develop and maintain global and EU risk‑management plans, assess risk‑minimization measures, and design post‑authorization safety studies.
• Leverage AI, automation, and digital platforms to continually enhance safety workflows and data analysis.

Education and Experience

• Scientific degree (BS, MS, PharmD, PhD, MD, RN, or equivalent).
• 4–6+ years of experience in pharmacovigilance, drug development, or the pharmaceutical industry.

Skills & Attributes

• Strong knowledge of global pharmacovigilance regulations and post‑marketing safety requirements.
• Analytical mindset capable of interpreting complex clinical, nonclinical, and real‑world safety data.
• Excellent organizational skills with the ability to manage competing timelines while maintaining quality.
• Collaborative and adaptable communication style, thriving in cross‑functional environments.
• Comfort with emerging technologies, including AI and digital safety tools.

Equal Employment Opportunity

Bristol Myers Squibb is an equal‑opportunity employer. We provide reasonable accommodations for persons with disabilities. The company considers qualified applicants with arrest and conviction records pursuant to applicable laws.

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