Manager, Patient Safety & PV Compliance, Standards, and Training
Corcept Therapeutics
August 10, 2026
On-site
Redwood City, CA
Medical Affairs
Key Responsibilities:
- Support operation and maintenance of the PSPV Quality Management System (QMS), ensuring consistent implementation aligned 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/refresher), including tracking training completion and related compliance KPIs.
- Develop, compile, and report PV compliance metrics/KPIs, including trend/performance assessment, compliance status, and improvement opportunities.
- Support PSPV inspection readiness (documentation preparation, mock inspections, support of regulatory inspections).
- Manage PSPV deviation, CAPA, and change control activities (investigation support, documentation, effectiveness checks).
- Monitor pharmacovigilance regulation/guideline changes and support procedural/training updates.
- Support review, update, and ongoing maintenance of the Pharmacovigilance System Master File (PSMF), coordinating routine reviews and updates 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) (plus).
- Strong organizational, documentation, and attention-to-detail skills.
- Effective written and verbal communication skills; ability to collaborate cross-functionally 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 experience, including 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 consistent implementation aligned 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/refresher), including tracking training completion and related compliance KPIs.
- Develop, compile, and report PV compliance metrics/KPIs, including trend/performance assessment, compliance status, and improvement opportunities.
- Support PSPV inspection readiness (documentation preparation, mock inspections, support of regulatory inspections).
- Manage PSPV deviation, CAPA, and change control activities (investigation support, documentation, effectiveness checks).
- Monitor pharmacovigilance regulation/guideline changes and support procedural/training updates.
- Support review, update, and ongoing maintenance of the Pharmacovigilance System Master File (PSMF), coordinating routine reviews and updates 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) (plus).
- Strong organizational, documentation, and attention-to-detail skills.
- Effective written and verbal communication skills; ability to collaborate cross-functionally 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 experience, including 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.