Neurocrine Biosciences
Sr. Specialist, DSPV Operations
US CA San Diego · Senior
Sponsorship not specified$103k-$141kDetected 8 days ago
Project ManagementExcelProcess ImprovementVendor ManagementFDA RegulatoryPharmacovigilanceCommunicationCollaborationProblem SolvingRegulatory Affairs
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odds of building a lasting career here
57Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level III)83
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~45% per draw at Level III). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
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Files H-1B transfers
6 transfer filings in the last year, covering 6 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.
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About the role
- Identifies opportunities for process improvement and participates in defined PV compliance improvement initiatives and workstreams.
- Your Contributions (include, but are not limited to):
Responsibilities
- Tracks quality and compliance issues through resolution and proactively follows up with responsible stakeholders to support timely completion of actions
- Collaborates cross-functionally (e.g. Clinical Operations, Quality, Regulatory Affairs) and other relevant stakeholders to support compliant PV processes as needed
- Experience developing, revising, or implementing SOPs, guidelines, work instructions, and related procedural documentation
- Experience working with outsourced PV vendors and/or business partners preferred
- Proficient with tools and processes that support work conducted by functional area
Requirements
- 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
- Expertise in clinical trial and post-marketed PV
- Strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas
- Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
- Team player with ability to function in a multi-disciplinary environment
Nice to have
- 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..
- Experience with process improvement initiatives preferred
Compensation
- The annual base salary we reasonably expect to pay is $103,300.00-$141,000.00.
Company info
- 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. _
- 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 )
- Biosciences is a leading biopharmaceutical company with a simple purpose:
- to relieve suffering for people with great needs.
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