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, but few options.

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. 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, 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, visitneurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

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• 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

• 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

• Strong knowledge of US and EU pharmacovigilance regulatory requirements

• Strong knowledge of current pharmacovigilance practices

• Knowledge of drug safety databases; experience with ARISg is a plus

• Ability to evaluate, interpret and synthesize scientific data

• Proficiency with safety safety coding dictionaries (eg, MedDRA, WHODRUG)

• Expertise in individual safety case report processing, including triage, data entry, quality review, and submission

• 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 environment

• Self-motivated, detail oriented, and able to prioritize and plan effectively

• Strong leadership and communication skills (both oral and written)

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Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.

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