Drug Safety Lead

📋 Description

• • The Drug Safety Lead is a critical role responsible for ensuring patient safety throughout clinical trial execution by overseeing pharmacovigilance activities, adverse event management, and regulatory compliance in oncology and rare disease studies.
• • Day-to-day responsibilities include leading safety budget reviews, developing safety management plans, overseeing serious adverse event (SAE) case processing from intake to regulatory reporting, preparing safety reports and medical coding plans, conducting safety training, managing SOPs, mentoring Safety Specialists, participating in audits and CAPA processes, supporting bid defenses, and serving as a subject matter expert for internal and external stakeholders.
• • Precision Medicine Group is a specialized CRO focused on accelerating life-changing therapies in oncology and rare disease through integrated clinical trial execution, scientific expertise, laboratory capabilities, and advanced data sciences, with a mission to improve the speed, cost, and success of drug development.
• • In this role, the individual will deepen expertise in global pharmacovigilance regulations, lead cross-functional safety initiatives, mentor junior safety professionals, influence safety strategy for oncology and rare disease programs, and gain visibility into end-to-end clinical trial safety management while contributing to the advancement of innovative cancer therapies.