Principal 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: Provide scientific/clinical expertise, strategic input, and support for deliverables and activities associated with clinical and post-market pharmacovigilance. Support signal management activities, safety and benefit-risk evaluations and author periodic safety reports (eg, PADER, DSUR, etc.) for assigned programs. Will be a key contributor to SOP development and revisions. May also work with the DSPV Operations group and assist with case processing activities as needed by the department. _ Your Contributions (include, but are not limited to): Safety Scientist Lead for assigned programs or studies. Provides clinical and operational safety support to the Clinical Development programs (eg, content review of protocols, study reports, Investigator Brochure, informed consents and other related documents, as applicable) Conduct literature review for assigned programs Lead the preparation of periodic safety reports (eg, PADER, DSURs) in accordance with regulatory requirements and standard operating procedure for assigned programs In collaboration with the DSPV Medical Director, performs aggregate safety data review and interpretation to support safety evaluations for assigned programs In collaboration with the DSPV Medical Director, perform signal detection and evaluation activities in accordance with SOPs and guidelines for assigned programs Participate in independent Data Monitoring Committee meetings, as applicable. Contribute to SOP and guidelines development and revisions Participates in multidisciplinary teams at Neurocrine involving R & D project teams, Clinical Operations, Regulatory, and others to execute clinical trials Support DSPV Operations with case processing activities as needed Other duties as assigned Requirements: BS/BA or RN degree in related scientific field AND 8+ years of experience in drug safety in the biotech/pharmaceutical industry with 3+ years of pharmacovigilance compliance experience. Experience in supporting regulatory authority inspections of GVP and process improvement initiatives. Experience with drug safety databases such as ARISg. Healthcare professional and vendor management experience preferred OR Master's degree in related scientific field AND 6+ years of similar experience noted above OR PhD or PharmD in related scientific field AND 4+ years of similar experience noted above Requires understanding of how the team / work area relates to other related areas and uses that knowledge to improve efficiency and produce high-quality work on problems with cross-functional impact Identifies and resolves technical, operational and organizational problems/problems relating to own discipline Frequently works cross-functionally as the representative for their area Team player with ability to function in a multi-disciplinary