Senior PV Compliance & Quality Operations

Neurocrine Biosciences; San Diego (CA); On-site; USD 103,000 - 141,000; Full time

Benefits offered by this job

Retirement plan

Paid time off

Parental and medical leave

Health benefits

Job summary

Neurocrine Biosciences in San Diego, CA seeks a Pharmacovigilance Compliance professional to support global PV quality management, including monitoring, CAPAs, inspection readiness, and documentation maintenance. The role collaborates with Clinical Operations, Quality, and Regulatory Affairs to ensure compliant PV processes across development and post‑marketing programs.

Strong knowledge of ICH guidelines and PV systems is required.

Qualifications

• BS/BA in scientific field and 4+ years in drug safety with 2+ years in PV compliance.
• Preferred: experience supporting regulatory inspections of GVP and process improvements.
• Strong knowledge of ICH guidelines and US/EU PV regulatory requirements.
• Experience developing or implementing PV SOPs, guidelines, and training materials.

Responsibilities

• Support PV compliance activities for programs in development and post‑approval.
• Coordinate PV deviations with documentation, investigations and CAPAs.
• Track issues to resolution and ensure timely corrective actions.
• Develop and revise PV procedures, guidelines, and work instructions.
• Support PV training and inspection readiness activities.
• Collaborate with Clinical Operations, Quality, and Regulatory Affairs.
• Interact with PV vendors and monitor adherence to PV procedures.

Skills

Pharmacovigilance

Drug safety

Analytical thinking

Problem solving

Communication

Project management

Team player

Education

BS/BA in scientific field

RN degree

Master's/PA/PharmD in scientific field

Tools

Argus

MS Excel

Job description

Neurocrine Biosciences in San Diego, CA seeks a Pharmacovigilance Compliance professional to support global PV quality management, including monitoring, CAPAs, inspection readiness, and documentation maintenance. The role collaborates with Clinical Operations, Quality, and Regulatory Affairs to ensure compliant PV processes across development and post‑marketing programs.

Strong knowledge of ICH guidelines and PV systems is required.