Senior Medical Scientist

Role: Senior Medical Scientist, Drug Safety, supporting the development and oversight of Arrowhead's investigational and post-marketing products with a focus on safety governance, signal detection, and regulatory compliance. Responsibilities: review safety observations, prepare aggregate safety reports (e.g., PSUR, DSUR), conduct signal detection, develop safety surveillance plans, support safety documentation for regulatory submissions, and assist with safety-related inspections. Collaborates closely with Drug Safety Operations, Medical Monitors, Clinical Ops, QA, Data Management, and Regulatory teams. Requirements: MD or DO with 8+ years industry/CRO experience, including 5+ years in pharmacovigilance or safety operations; expertise in safety data analysis, signal detection, and safety reporting regulations (FDA, ICH, EMA). Experience with ARGUS, MedDRA, and safety data analytic tools is essential. Preferred: background in cardiometabolic or rare diseases. Work setup: onsite in San Diego, CA. The role involves active medical review, active case follow-up, and preparation of safety documentation for regulatory submissions.