Principal Scientist, Safety

Role: Safety Scientist Lead in pharmacovigilance for neuropharmaceuticals, providing scientific expertise and strategic support for safety monitoring and signal management across clinical development and post-market phases. Responsibilities: oversee safety data review, prepare periodic safety reports (e.g., PADER, DSUR), support SOP development, collaborate on safety evaluations and signal detection, and contribute to multidisciplinary clinical and regulatory teams. Requirements: BS/BA or RN with 8+ years of drug safety experience, or Master's/PhD/PharmD with proportionally fewer years; strong knowledge of US/EU pharmacovigilance regulations, safety databases (ARISg preferred), and coding standards like MedDRA and WHODRUG; excellent communication and cross-functional collaboration skills; experience supporting regulatory inspections and process improvements. HighValue: focus on neurological, psychiatric, endocrine, or immunological disorders; expertise in clinical safety, signal detection, and safety report preparation; relevant for roles supporting early to late-phase clinical trials, with a focus on regulatory compliance. WorkSetup: not specified, but likely office-based with cross-functional interactions.