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:
Responsible for Pharmacovigilance (PV) Compliance and strengthening and advancing Neurocrine’s pharmacovigilance quality management system. Serves as an expert in global pre- and post-marketing safety compliance and will manages all DSPV quality and compliance activities. Works independently and acts as PV Compliance liaison cross-functionally within Neurocrine as well as to Neurocrine’s PV vendors and business partners._
Your Contributions (include, but are not limited to): Manage all DSPV quality and compliance activities for programs in development and post approval, including establishing compliance metrics and compliance monitoringManage deviations and CAPAs (corrective and preventative actions)Facilitate SOP and guidelines development and revisions, as well as trainingManage inspection readiness activities and participate in auditsPlay a key role in supporting the development and maintenance of Pharmacovigilance System Master File (PSMF).Establish regulatory reporting requirements matrices per global requirementsLead process improvements projects within DSPVOther duties as assignedRequirements: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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The annual base salary we reasonably expect to pay is $127,500.00-$184,800.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.