Scientist, Safety
Core
Supports safety surveillance and risk management activities for assigned Neurocrine products through the product lifecycle, including signal management, regulatory reporting, and health authority responses.
Role type
Scientist, Safety (Pharmacovigilance)
Builds
Safety reports, regulatory submissions, and risk management plans for neurological, psychiatric, endocrine, and immunological treatments.
Domain
Biopharmaceuticals / Pharmacovigilance
Required skills
Pharmacovigilance regulatory requirements knowledge, signal evaluation, risk management, aggregate data analysis, scientific data interpretation, regulatory document preparation, SOP maintenance, scientific literature review, drug safety system proficiency (ARISg, Argus), multidisciplinary team collaboration.
Preferred skills
MS/MA in related scientific field, PharmD or PA, clinical trial experience, experience with new drug applications.
Technologies
ARISg, Argus, MedDRA, DSUR, IND Annual Report, PADER, PBRER, PSUR, ISS, CCDS.
Responsibilities
Participate in safety signal management to detect, analyze, and investigate safety signals; Execute risk management plans for assigned products; Perform safety data review and interpret information; Support preparation of safety input for regulatory reports and clinical study documents; Assist preparation of periodic and ad-hoc aggregate reports; Participate in multidisciplinary teams to execute clinical trials and develop product development plans; Collect responses to safety questions from stakeholders; Review scientific literature for safety information; Support clinical trial PV activities including protocol and report reviews; Assist with document requests and responses during inspections and audits.
Seniority
Mid-level, hands-on IC