Description
Precision for Medicine is seeking a Safety Specialist/Safety Lead to manage clinical trial safety activities, including safety management plans, serious adverse event and SUSAR case management, regulatory reporting, safety databases, ICSR preparation, quality control, reporting plans, training, and safety procedures. The role requires a BA/BS degree, at least five years of safety experience, healthcare professional status, and hands-on experience with global safety databases, SAE processing, narrative writing, and safety reports, along with knowledge of MedDRA, WHODrug, FDA regulations, ICH guidelines, and global safety regulations.
