Associate Director, Patient Safety Scientist

Associate Director leading patient safety assessment and signal detection for Bristol Myers Squibb's development and marketed medicines. Serves as strategic advisor to safety management teams, manages pharmacovigilance compliance, and evaluates emerging safety evidence to support regulatory submissions and risk management planning.

Responsibilities

• Drive signal detection and safety assessment activities in collaboration with Safety Management Team leadership
• Lead safety data review meetings and escalate portfolio issues impacting key programs and milestones
• Author aggregate safety documents, regulatory submissions, and health authority responses with comprehensive analysis
• Develop and maintain global Risk Management Plans and additional risk minimization measures across markets
• Support clinical development through safety sections in protocols, study reports, investigator brochures, and consent forms

Requirements

• Scientific degree (BS, MS, RN, PharmD, PhD, MD) or equivalent relevant experience
• Expertise in signal detection, safety surveillance, and pharmacovigilance throughout product lifecycle
• Strong medical writing skills for regulatory safety documents and clinical trial materials
• Experience with risk management planning, aggregate safety reports, and regulatory submissions
• Proficiency with safety data sources, tools, and quantitative signal detection methods
• Knowledge of health authority interactions and global pharmacovigilance compliance requirements