Sr. Specialist, DSPV Operations
Neurocrine Biosciences
Summary
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.
Job description
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.
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
- 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)
Benefits
- 401(k) Matching
- Paid Vacation
- Holiday & Personal Days
- Paid Caregiver/Parental Leave
- Medical Leave
- Medical, Dental & Vision
- Prescription Drug Coverage
- Annual Bonus
- Equity Long-Term Incentive
Company overview
Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company founded in 1992 and headquartered in San Diego, California. The company specializes in discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Neurocrine's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis, and uterine fibroids. Their flagship product, INGREZZA (valbenazine), was the first FDA-approved treatment for adults with tardive dyskinesia. The company maintains a robust pipeline with multiple compounds in mid- to late-phase clinical development across core therapeutic areas, including Parkinson's disease, Tourette syndrome, and major depressive disorder. Neurocrine operates with a purpose to relieve suffering for people with great needs, applying unique insights into neuroscience and the interconnections between brain and body systems to treat complex conditions. The company is publicly traded on NASDAQ under the symbol NBIX and has established strategic collaborations with major pharmaceutical partners including AbbVie.