
Safety Lead
Responsible for oversight of clinical safety and pharmacovigilance activities (SAE/SUSAR intake to regulatory reporting), development of safety plans and SOPs, QC and training, audit/inspection support, and serving as subject matter expert and project manager for safety initiatives. Requires a BA/BS, 10+ years clinical safety experience and 5+ years PV experience; hands-on experience with global safety databases, MedDRA, WHODrug, and relevant regulations.