Manager, Patient Safety & Pv Compliance, Standards, And Training
Corcept Therapeutics
Redwood City, California, United States
Base: $160,000 – $200,000; bonus/equity: not speci...
On-site
Patient safety pharmacovigilance compliance
Fda ema ich regulatory knowledge
Quality management system maintenance
Corcept Therapeutics is seeking a Manager for Patient Safety & Pharmacovigilance Compliance, Standards, and Training, responsible for overseeing PSPV compliance activities, maintaining quality management systems, and ensuring adherence to regulatory standards. The ideal candidate will have a strong background in pharmacovigilance, quality systems, and training development, with at least five years of relevant experience
Job Summary
The role supports the execution and day-to-day oversight of Patient Safety and Pharmacovigilance compliance activities including metrics and procedures.
Candidates will manage the development and implementation of role-based PV training programs while monitoring compliance metrics and KPIs.
This position requires supporting inspection readiness activities and maintaining the Pharmacovigilance System Master File across functions and vendors.
Matching Summary
Match Score: 85
Corcept Therapeutics is seeking a Manager for Patient Safety & Pharmacovigilance Compliance, Standards, and Training, responsible for overseeing PSPV compliance activities, maintaining quality management systems, and ensuring adherence to regulatory standards. The ideal candidate will have a strong background in pharmacovigilance, quality systems, and training development, with at least five years of relevant experience.
Salary
Base: $160,000 – $200,000; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
Patient Safety Pharmacovigilance compliance
FDA EMA ICH regulatory knowledge
Quality Management System maintenance
Deviation CAPA change control management
PV training program development
Nice-to-have
Veeva or similar QMS experience
Inspection and audit support skills
Project management capabilities
Advanced degree in life sciences
Cross-functional collaboration skills
Key Requirements
Bachelor's degree in life sciences or healthcare
Minimum 5 years Patient Safety/PV experience
2+ years in PV compliance standards or quality systems
Experience managing deviations CAPAs and change controls
Authorized to work in the United States full-time
Work Rights
Must be currently authorized to work in the United States on a full-time basis