Manager, Patient Safety & PV Compliance, Standards, and Training
Corcept Therapeutics
June 28, 2026
On-site
Redwood City, CA
Operations
Key Responsibilities:
- Support operation and maintenance of the PSPV Quality Management System (QMS), ensuring procedures and processes align with regulatory requirements
- Author, review, revise, and maintain PSPV procedures, work instructions, and controlled documents in compliance with global PV regulations (FDA, EMA, ICH)
- Develop, implement, and maintain role-based PV training programs (initial and refresher), monitoring training completion and compliance KPIs
- Develop, compile, and report PV compliance metrics/KPIs, assess performance trends, and identify improvement opportunities
- Support PSPV inspection readiness (documentation preparation, mock inspections, and regulatory inspections)
- Manage deviations, CAPA, and change control activities related to PSPV processes (investigation support, documentation, effectiveness checks)
- Monitor changes in pharmacovigilance regulations/guidelines and support updates to procedures and training
- Support ongoing review, update, and maintenance of the Pharmacovigilance System Master File (PSMF) across functions and vendors
Required Skills and Qualifications:
- Ability to operate effectively in a regulated, fast-paced environment while managing multiple priorities
- Strong working knowledge of pharmacovigilance regulations and guidelines (FDA, EMA, ICH)
- Experience with Quality Management Systems (e.g., Veeva or similar) is a plus
- Strong organizational, documentation, and attention-to-detail skills
- Effective written and verbal communication; ability to collaborate across functions and with external vendors
Education and Experience:
- Bachelor’s degree in life sciences/healthcare/related field; advanced degree (e.g., RN, BSN, PharmD) preferred
- Minimum 5 years Patient Safety/PV with 2+ years in PV compliance, standards, training, or quality system activities
- Experience managing quality events (deviations, CAPAs, change controls)
- Inspection/audit support experience and project management skills preferred
Application Instructions:
- Applicants must be currently authorized to work in the United States on a full-time basis.
- Support operation and maintenance of the PSPV Quality Management System (QMS), ensuring procedures and processes align with regulatory requirements
- Author, review, revise, and maintain PSPV procedures, work instructions, and controlled documents in compliance with global PV regulations (FDA, EMA, ICH)
- Develop, implement, and maintain role-based PV training programs (initial and refresher), monitoring training completion and compliance KPIs
- Develop, compile, and report PV compliance metrics/KPIs, assess performance trends, and identify improvement opportunities
- Support PSPV inspection readiness (documentation preparation, mock inspections, and regulatory inspections)
- Manage deviations, CAPA, and change control activities related to PSPV processes (investigation support, documentation, effectiveness checks)
- Monitor changes in pharmacovigilance regulations/guidelines and support updates to procedures and training
- Support ongoing review, update, and maintenance of the Pharmacovigilance System Master File (PSMF) across functions and vendors
Required Skills and Qualifications:
- Ability to operate effectively in a regulated, fast-paced environment while managing multiple priorities
- Strong working knowledge of pharmacovigilance regulations and guidelines (FDA, EMA, ICH)
- Experience with Quality Management Systems (e.g., Veeva or similar) is a plus
- Strong organizational, documentation, and attention-to-detail skills
- Effective written and verbal communication; ability to collaborate across functions and with external vendors
Education and Experience:
- Bachelor’s degree in life sciences/healthcare/related field; advanced degree (e.g., RN, BSN, PharmD) preferred
- Minimum 5 years Patient Safety/PV with 2+ years in PV compliance, standards, training, or quality system activities
- Experience managing quality events (deviations, CAPAs, change controls)
- Inspection/audit support experience and project management skills preferred
Application Instructions:
- Applicants must be currently authorized to work in the United States on a full-time basis.