Job Description

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. Our portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, congenital adrenal hyperplasia, endometriosis, and uterine fibroids, along with a robust pipeline in clinical development. For over three decades, we have applied our neuroscience expertise to treat complex conditions, relentlessly pursuing medicines to ease the burden of debilitating diseases because you deserve brave science. For more information, visit neurocrine.com and follow us on LinkedIn, X, and Facebook. (*in collaboration with AbbVie )

About the Role:

Provide scientific/clinical expertise, strategic input, and support for deliverables and activities related to clinical and post-market pharmacovigilance. Support signal management, safety and benefit-risk evaluations, and author periodic safety reports (e.g., PADER, DSUR). Contribute to SOP development and revisions. Assist with case processing activities as needed by the DSPV Operations team.

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

• Serve as Safety Scientist Lead for assigned programs or studies, providing clinical and operational safety support to Clinical Development, including review of protocols, study reports, Investigator Brochures, informed consents, and related documents.
• Conduct literature reviews for assigned programs.
• Lead the preparation of periodic safety reports (e.g., PADER, DSURs) in compliance with regulatory requirements and SOPs.
• Collaborate with the DSPV Medical Director to review and interpret safety data, supporting safety evaluations.
• Perform signal detection and evaluation activities according to SOPs and guidelines.
• Participate in Data Monitoring Committee meetings, as applicable.
• Contribute to SOP and guideline development and revisions.
• Engage with multidisciplinary teams across R&D, Clinical Operations, Regulatory, and others to execute clinical trials.
• Support case processing activities within DSPV Operations.
• Perform other duties as assigned.

Requirements:

• BSc/BA or RN in a related scientific field with 8+ years of drug safety experience, including 3+ years in pharmacovigilance compliance, experience with regulatory inspections, and drug safety databases like ARISg. Healthcare professional and vendor management experience preferred.
• Master's degree with 6+ years of relevant experience.
• PhD or PharmD with 4+ years of relevant experience.
• Understanding of cross-functional team dynamics and ability to improve efficiency and quality.
• Strong problem-solving, collaboration, attention to detail, and scientific data analysis skills.
• Excellent communication and leadership skills, with knowledge of US and EU pharmacovigilance regulations.
• Experience with drug safety databases such as ARGUS and Empirica is a plus.
• Proficiency with MedDRA, WHODRUG coding dictionaries, and safety case processing.

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Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to a workplace of belonging, respect, and empowerment. We encourage candidates to apply regardless of experience or qualifications that may not perfectly match the job description.

The expected annual base salary range is $128,200 - $185,900, depending on location, experience, and responsibilities. This position includes an annual bonus target of 30%, participation in our long-term incentive program, and benefits such as retirement plans, paid time off, parental leave, and comprehensive health coverage.

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