Scientist, Safety

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit  neurocrine.com , and follow the company on  LinkedIn ,  X , Facebook and YouTube . ( *in collaboration with AbbVie ) About the Role: Supports safety surveillance and risk management activities for assigned Neurocrine products through the lifecycle of the product. Supports the production of aggregate reports, signal management and safety review meetings, providing safety support for investigational products including new drug applications and other regulatory filings, managing responses to health authorities and maintaining relationships with PV business partners. May also work with the DSPV Operations group to support case processing activities as needed by the department. _ Your Contributions (include, but are not limited to): Participate in the process of safety signal management to detect, analyze, and investigate safety signals Executes risk management plans for assigned Neurocrine products during all phases of development and post approval Perform assigned safety data review and may interpret information to support safety evaluations Support preparation of safety input (e.g., author and review) for drug-safety related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), MedDRA coding of AEs, product labeling, Company Core Data Sheet (CCDS)) Assist preparation of safety related regulatory submission documents including periodic and ad-hoc aggregate reports (eg, DSUR, IND Annual Report, PADER, PBRER, PSUR, etc.) and safety-related health authority requests in accordance with regulatory requirements Participate in multidisciplinary teams at Neurocrine involving R & D project teams, clinical project managers, business management, regulatory, and others to execute clinical trials, assess new product opportunities, develop clinical research strategy and product development plans Participate in testing processes and conventions for safety surveillance activities including maintenance of SOPs and guidelines Collects responses to safety questions from internal and external stakeholders including business partners Perform review of scientific literature for safety information Support clinical trial PV activities including providing safety content review of clinical protocols, study reports, Investigators Brochure, informed consents and other related documents, as applicable Assist with document requests and preparing responses during inspections and audits as well as management of any corrective and preventative actions Other duties as assigned Requirements: BS/BA degree in related scientific field or RN degree AND 2+ years of pharmacovigilance or clinical and/or medical research or equivalent experience OR MS/MA degree in related scientific field AND some relevant industry experience preferred OR PharmD or PA AND some experience preferred Recognizes fundamental anomalies in data