Sr. Specialist, DSPV Operations

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, 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 more than 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, Facebook and YouTube. (*in collaboration with AbbVie)

About the Role:

Supports Pharmacovigilance (PV) Compliance activities and the continued development and maintenance of Neurocrine’s pharmacovigilance quality management system. Supports global pre- and post-marketing safety compliance activities, including compliance monitoring, quality issue management, inspection readiness, procedural document management, training, and maintenance of key PV compliance documentation.

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

• Supports DSPV quality and compliance activities for programs in clinical development and post-approval
• Coordinates and supports the management of PV deviations (internally and with vendors), including documentation, investigation, root cause analysis, corrective and preventive actions (CAPAs), and effectiveness checks, as applicable
• Tracks quality and compliance issues through resolution and proactively follows up with responsible stakeholders to support timely completion of actions
• Supports the development, revision, periodic review, and implementation of DSPV standard operating procedures, guidelines, work instructions, and other controlled documents
• Supports PV training activities, including development and maintenance of training materials and monitoring of training completion, as applicable
• Supports ongoing PV inspection readiness activities, including maintenance of inspection-ready documentation, preparation of requested materials and tracking of resulting commitments and actions
• Collaborates cross-functionally (e.g. Clinical Operations, Quality, Regulatory Affairs) and other relevant stakeholders to support compliant PV processes as needed
• Interacts with PV vendors on defined compliance activities and supports monitoring of adherence to applicable PV procedures, agreements, and regulatory requirements
• Identifies opportunities for process improvement and participates in defined PV compliance improvement initiatives and workstreams.
• Other duties as assigned

Requirements:

• BS/BA in a scientific field or RN degree AND 4+ years in drug safety in the biotech/pharmaceutical industry with 2+ years of pharmacovigilance compliance experience. Preferred experience: Experience in supporting regulatory authority inspections of GVP and process improvement initiatives.. Healthcare professional and vendor management experience preferred OR
• Master's, PA or PharmD in scientific field AND 2+ years of similar experience noted above
• Strong knowledge of ICH guidelines, US and EU pharmacovigilance regulatory requirements
• Knowledge of pharmacovigilance quality management systems and compliance principles
• Knowledge of regulatory authority inspection and audit processes preferably with experiencing supporting pharmacovigilance inspections and/or audits
• Experience developing, revising, or implementing SOPs, guidelines, work instructions, and related procedural documentation
• Experience working with outsourced PV vendors and/or business partners preferred
• Experience with process improvement initiatives preferred
• Expertise in clinical trial and post-marketed PV
• Understands key business drivers and uses this understanding to accomplish work
• Strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas
• Proficient with tools and processes that support work conducted by functional area
• Strong communications, problem-solving, analytical thinking skills.
• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
• Strong project management skills
• Team player with ability to function in a multi-disciplinary environment
• Self-motivated, detail oriented, and able to prioritize and plan effectively
• Strong technical skills / software skills (i.e., MS Excel) and drug safety databases(e.g., Argus)

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Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, 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 $103,300.00-$141,000.00. 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 20% 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.