Principal Specialist, Safety

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, but few options.

What We Do:

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, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

Key contributor to the success of the Drug Safety and Pharmacovigilance department. Works under the direction of the Manager and Director of DSPV Operations on DSPV Operations activities. Provide support for oversight of case processing activities, supporting signal detection activities, pharmacovigilance compliance activities and safety system related activities.

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

• Provide oversight on outsourced safety-related functions.

• Perform adequate case reviews for cases that are processed by PV Case processing Vendor and 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

Requirements:

• 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