Drug Safety Lead

📋 Description

• • The Drug Safety Lead plays a critical role in ensuring patient safety and regulatory compliance in clinical trials, directly supporting the development of life-changing therapies in oncology and rare diseases.
• • Day-to-day responsibilities include managing serious adverse event (SAE) case processing from intake to regulatory reporting, developing safety management plans, interfacing with sponsors and vendors on safety data collection tools, reviewing safety reports and documents, preparing safety training materials, and serving as a subject matter expert for the safety/pharmacovigilance team.
• • Precision for Medicine is a specialized CRO that integrates clinical trial execution with scientific expertise, laboratory capabilities, and advanced data sciences to improve the speed, cost, and success of bringing therapies to patients, with a strong focus on oncology and rare disease.
• • In this role, the individual will lead departmental initiatives, mentor Safety Specialists, manage safety standalone projects, participate in audits and bid defenses, and contribute to regulatory interactions—gaining deep expertise in global pharmacovigilance while driving process improvements and cross-functional collaboration.