Senior Manager, Pharmacovigilance Scientist

Senior Manager, Pharmacovigilance Scientist at Bristol Myers Squibb leads signal detection, safety surveillance, and risk management activities across the product lifecycle. The role partners with medical safety teams to characterize safe medicine use, manage regulatory compliance, and support clinical development and postmarketing activities.

Responsibilities

• Perform signal detection and assessment activities with review of safety literature and quantitative analysis
• Lead safety data review meetings and escalate issues impacting safety management team priorities
• Prepare and maintain risk management plans, integrated safety documents, and regulatory submissions
• Author safety sections of clinical trial documents, marketing authorization applications, and labeling updates
• Develop and coordinate risk minimization measures and additional pharmacovigilance activities globally

Requirements

• Scientific degree such as BS, MS, RN, PharmD, PhD, or MD
• Core competency in signal detection and safety assessment throughout product lifecycle
• Experience with safety data analysis and utilization of pharmacovigilance tools and databases
• Demonstrated capability in regulatory compliance and safety documentation preparation
• Ability to lead cross-functional collaboration and communicate with health authorities
• Knowledge of risk management planning and postmarketing safety surveillance