Sr. Specialist, DSPV Operations

About This Role

Supporting Pharmacovigilance (PV) Compliance activities and the ongoing development and maintenance of Neurocrine’s pharmacovigilance quality management system is the core of this role. It involves 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.

Responsibilities

• Support DSPV quality and compliance activities for programs in clinical development and post-approval
• Coordinate and support 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
• Track quality and compliance issues through resolution and proactively follow up with responsible stakeholders to support timely completion of actions
• Support the development, revision, periodic review, and implementation of DSPV standard operating procedures, guidelines, work instructions, and other controlled documents
• Support PV training activities, including development and maintenance of training materials and monitoring of training completion, as applicable
• Support ongoing PV inspection readiness activities, including maintenance of inspection-ready documentation, preparation of requested materials and tracking of resulting commitments and actions
• Collaborate cross-functionally (e.g. Clinical Operations, Quality, Regulatory Affairs) and other relevant stakeholders to support compliant PV processes as needed
• Interact with PV vendors on defined compliance activities and support monitoring of adherence to applicable PV procedures, agreements, and regulatory requirements
• Identify opportunities for process improvement and participate in defined PV compliance improvement initiatives and work streams
• Perform 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
• 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

Nice to have:

• Experience in supporting regulatory authority inspections of GVP and process improvement initiatives