Senior Medical Safety Scientist

Role: Senior Medical Safety Scientist within Drug Safety & Pharmacovigilance, serving as the primary scientific safety lead for Acadia's portfolio of neurological and rare disease therapeutics. Key responsibilities include conducting safety data review from clinical and post-marketing sources, leading signal detection and safety evaluation, authoring safety assessments and regulatory safety documents, and supporting pharmacovigilance activities like RMPs and safety governance. The role involves close collaboration with Safety Physicians, cross-functional teams, and regulatory bodies to ensure safety monitoring compliance throughout the product lifecycle. Requirements: PharmD, PhD, MS, MSN, MPH, RN, NP, PA, or equivalent, with 7+ years in drug safety, pharmacovigilance, or clinical safety within pharma or biotech industries. Deep expertise in safety surveillance, signal management, benefit-risk assessments, and regulatory documentation, with proficiency in safety databases (e.g., Argus), MedDRA coding, and global PV regulations (FDA, EU, ICH). Preferred: experience supporting safety in neuroscience indications such as Parkinson’s disease psychosis, Rett syndrome, Alzheimer’s, Lewy body dementia, or related post-marketing surveillance. The position is based in San Diego, CA, or Princeton, NJ, with a hybrid work model (3 days onsite). Domestic and international travel may be required.