Drug Safety Lead

📋 Description

• • As a Drug Safety Lead at Precision for Medicine, you will play a critical role in ensuring patient safety and regulatory compliance in clinical trials, particularly in oncology and rare disease therapeutic areas, by leading pharmacovigilance activities and supporting the development and execution of safety strategies.
• • Day to day, you will interface with sponsors, vendors, and internal teams to design and implement safety collection tools, oversee serious adverse event (SAE) case management from intake to regulatory reporting, prepare and review safety reporting and medical coding plans, develop safety training materials, manage safety budgets, and serve as a subject matter expert providing timely safety expertise to team members, clients, and study site personnel.
• • You will join a specialized team within Precision for Medicine, a differentiated CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed, cost, and success rate of bringing life-changing therapies to patients, with a strong focus on oncology and rare disease.
• • In this role, you will develop leadership and strategic impact by mentoring Safety Specialists, leading departmental initiatives and cross-functional activities, managing safety standalone projects as a project manager, participating in audits and CAPA processes, and contributing to bid defenses and resource management, thereby advancing your expertise in global pharmacovigilance and regulatory affairs.