Sr. Specialist, DSPV Operations

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 Pharmacovigilance (PV) Compliance activities and the continued development and maintenance of Neurocrine’s pharmacovigilance quality management system. Supports global pre- and post-marketing safety compliance activities, including compliance monitoring, quality issue management, inspection readiness, procedural document management, training, and maintenance of key PV compliance documentation. _ Your Contributions (include, but are not limited to): Supports DSPV quality and compliance activities for programs in clinical development and post-approval Coordinates and supports the management of PV deviations (internally and with vendors), including documentation, investigation, root cause analysis, corrective and preventive actions (CAPAs), and effectiveness checks, as applicable Tracks quality and compliance issues through resolution and proactively follows up with responsible stakeholders to support timely completion of actions Supports the development, revision, periodic review, and implementation of DSPV standard operating procedures, guidelines, work instructions, and other controlled documents Supports PV training activities, including development and maintenance of training materials and monitoring of training completion, as applicable Supports ongoing PV inspection readiness activities, including maintenance of inspection-ready documentation, preparation of requested materials and tracking of resulting commitments and actions Collaborates cross-functionally (e.g. Clinical Operations, Quality, Regulatory Affairs) and other relevant stakeholders to support compliant PV processes as needed Interacts with PV vendors on defined compliance activities and supports monitoring of adherence to applicable PV procedures, agreements, and regulatory requirements Identifies opportunities for process improvement and participates in defined PV compliance improvement initiatives and workstreams. Other duties as assigned Requirements: BS/BA in a scientific field or RN degree AND 4+ years in drug safety in the biotech/pharmaceutical industry with 2+ years of pharmacovigilance compliance experience.

Experience in supporting regulatory authority inspections of GVP and process improvement initiatives.. Healthcare professional and vendor management experience preferred OR Master's, PA or PharmD in scientific field AND 2+ years of similar experience noted above Strong knowledge of ICH guidelines, US and EU pharmacovigilance regulatory requirements Knowledge of pharmacovigilance quality management systems and compliance principles Knowledge of regulatory authority inspection and audit processes preferably with experiencing supporting pharmacovigilance inspections and/or audits Experience developing, revising, or implementing SOPs, guidelines,