Sr. Specialist, Safety

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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 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 and Facebook. (*in collaboration with AbbVie)

About the Role:

Support pharmacovigilance (PV) Operations activities including vendor oversight, case processing and submission. Develops and implements PV guidelines and ensures the uniform and timely processing of adverse event for NBI compounds in clinical development and post-approval. Ensures compliance with standard operating procedures and global regulations. The Sr. Specialist, Safety will work independently, with limited supervision.

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Your Contributions (include, but are not limited to):

• Provide oversight of outsourced safety-related functions

• Coordinates and performs adverse event data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities to comply with protocol and regulatory specific requirements

• Prepare for expedited reporting of SAEs, including preparation of analysis of similar events

• Support the preparation of periodic safety reports in accordance with regulatory requirements and standard operating procedure

• Support signal detection and evaluation activities in accordance with SOPs and guidelines

• Participates in developing DSPV Operations SOPs and guidelines and provides staff training

• Acts as liaison to vendor for case processing activities and ensures adherence to processes and regulatory requirements

• Develops study specific case processing reference information for staff and provides training

• Supports safety database activities as needed

• Other duties as assigned

Requirements:

• BS/BA in a scientific field or RN degree and 4+ years of pharmacovigilance or clinical and/or medical research or equivalent experience. Experience in and knowledge of drug safety databases (e.g., ARISg, Argus), signal evaluation and risk management, aggregate data analysis, interpretation and synthesis, and authoring periodic aggregate safety reports (e.g. PBRERs, DSURs) and RMPs. OR

• Master’s degree in scientific field and 2+ years o