Principal Specialist, Safety

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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• Provide oversight on outsourced safety-related functions.

• Perform adequate case reviews for cases that are processed by PV Case processing Vendorand provide guidance as needed

• Manage expedited reporting of SAEs from Clinical Trials, including preparation of analysis of similar events as needed

• Support the generation 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 and updating DSPV Operations SOPs and guidelines and provides staff training

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

• Support Study Start up activities including but not limited to development of training documents for new studies, review of study specific safety management plans (SMPs)

• Support Pharmacovigilance compliance related activities including but not limited to Submission compliance report generation, tracking of vendor deviations, CAPAs etc.

• Support safety database validation activities involving but not limited to review of validation documents, perform validation testing for safety system changes if needed, collaborate with IT and system administrator for system updates

• Contribute to inspection readiness related activities as needed

• May perform other duties as needed

• BS/BA degree in related scientific field and 6+ years of relevant experience OR

• Master's degree and 4+ years of related experience OR

• PharmD or PhD and 2+ years of related experience

• Strong knowledge of ICH guidelines, US and EU pharmacovigilance regulatory requirements

• Experience and knowledge of drug safety systems (Argus preferred)

• Strong knowledge of current pharmacovigilance practices

• Team player with ability to function in a multi-disciplinary environment

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

• Vendor management experience preferred

• Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines

• Works to improve tools and processes within functional area

• Developing reputation inside the company as it relates to area of expertise

• Ability to work as part of and lead multiple teams

• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams

• Excellent computer skills

• Excellent communications, 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 project management skills

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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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