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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• Performs safety signal management related activities to detect, analyze, and investigate safety signals

• Develops and manages risk strategies for Neurocrine products (all phases of development and post approval)

• Manages on-going product safety in support of the safety governance process

• Performs aggregate safety data review and interpretation to support safety evaluations

• Authors, reviews and provides input for drug-safety related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), MedDRA coding of AEs, product labeling, Company Core Data Sheet (CCDS))

• Authors, reviews, and provides input to safety related regulatory submission documents including periodic safety reports (e.g., DSUR, IND Annual Report, PADER, PBRER, PSUR, etc.) and responses to regulatory inquiries

• Performs medical review of individual case safety reports, including summarization, coding, seriousness, expectedness and Company causality assessment of investigational and/or marketed products

• Serves as the Safety Physician Lead for designated indications or drug portfolio(s)

• Participates in multidisciplinary teams at Neurocrine involving R & D project teams, clinical project managers, business management, regulatory, and others to execute clinical trials, assess new product opportunities, develop clinical research strategy and product development plans

• Participates in developing processes and conventions for safety surveillance activities

• Other duties as assigned

• M.D. degree plus accredited residency in relevant clinical specialty (eg, Internal Medicine, Family Practice, Neurology) and Board certification and clinical/industry experience required. 5+ years relevant experience

• Experience in pharmacovigilance in a pharmaceutical (preferably) or biotechnology company with experience in signal management (e.g., signal detection, evaluation, assessment)

• Excellent oral, written and presentation skills

• Strong leadership skills

• Excellent teamwork and interpersonal skills are required

• Excellent problem-solving, analytical thinking skills

• Sees broader picture, impact on multiple departments/divisions

• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

• Excellent organizational and project management skills

• Ability to lead and conduct individual safety case report processing, including triage, medical review and safety data summarization and analysis

• Knowledge of and ability to apply international regulatory authority regulations (especially FDA and EU/EEA)

• Knowledge of and ability to apply pre- and post-marketing drug safety standards

#LI-TM1

• Proficiency with safety databases (ARISg preferred) and safety coding dictionaries (e.g., MedDRA, WHODRUG)

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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