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 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, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple 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. *in collaboration with AbbVie

About the Role:

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• Manage all DSPV quality and compliance activities for programs in development and post approval, including establishing compliance metrics and compliance monitoring

• Manage deviations and CAPAs (corrective and preventative actions)

• Facilitate SOP and guidelines development and revisions, as well as training

• Manage inspection readiness activities and participate in audits

• Play a key role in supporting the development and maintenance of Pharmacovigilance System Master File (PSMF).

• Establish regulatory reporting requirements matrices per global requirements

• Lead process improvements projects within DSPV

• Other duties as assigned

• BS/BA in related scientific field or RN degree and 6 years of experience in drug safety in the biotech/pharmaceutical industry with 3 years of pharmacovigilance compliance experience. Preferred experience: Experience in supporting regulatory authority inspections of GVP and process improvement initiatives. Experience with drug safety databases such as Argus. Healthcare professional and vendor management experience preferred OR

• Master's degree in related scientific field and 4 years of similar experience noted above OR PharmD, PhD, PA in related scientific field and 4 years of similar experience noted above Some managerial / functional management or lead experience is a plus

• Strong knowledge of US and EU pharmacovigilance regulatory requirements.

• Strong knowledge of current pharmacovigilance practices.

• Ability to evaluate, interpret and synthesize scientific data.

• Expert knowledge in global pre- and post-marketing safety, manages all DSPV quality and compliance activities

• Strong knowledge of regulatory authority inspection process with a focus on pharmacovigilance.

• Understanding of audit/compliance program design

• Experience with PSMF development and maintenance

• Strong knowledge of drug safety databases, experience with Argus Safety is a plus

• Strong technical skills

• 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 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

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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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