Senior Medical Safety Scientist

Role: Senior Medical Safety Scientist, serving as the primary scientific safety expert within Drug Safety & Pharmacovigilance for Acadia's portfolio of neurological and rare disease therapies. Responsibilities include leading safety surveillance, signal detection, safety data review across clinical and post-marketing sources, authoring safety documentation, supporting regulatory submissions, and ensuring compliance with GVP and global regulations. The role involves close collaboration with Safety Physicians and cross-functional teams such as Clinical Development, Regulatory Affairs, and Medical Affairs, to evaluate and communicate safety risks. Requirements: PharmD, PhD, or equivalent degree; 7+ years in drug safety, pharmacovigilance, or clinical safety within pharma/biotech sectors; expertise in signal detection, benefit-risk assessment, safety data analysis, and regulatory document authoring; proficiency with safety databases like Argus; strong knowledge of FDA, EU, ICH guidelines. High-Value: focus on neurological indications, including Parkinson’s disease psychosis, Rett syndrome, Alzheimer’s disease psychosis, Lewy body dementia, across late-stage development and post-marketing phases; involvement in safety monitoring, signal validation, risk assessment, and regulatory compliance. Work setup: hybrid model based in San Diego or Princeton, with domestic and international travel as needed.