Support operation and maintenance of the PSPV Quality Management System (QMS), ensuring procedures and processes are implemented consistently and in alignment with regulatory requirements
Author, review, revise, and maintain PSPV procedures, work instructions, and related controlled documents in compliance with global PV regulations (FDA, EMA, ICH)
Contribute to and manage activities for the development, implementation, and maintenance of role-based PV training programs, including initial and refresher training as well as monitoring of training completion and related compliance metrics/key performance indicators (KPIs)
Contribute to and manage activities for the development, compilation and reporting of PV compliance metrics and KPI activities, including assessment of performance trends, compliance status, and identification of potential areas for improvement
Support PSPV inspection readiness activities, including preparation of documentation, participation in mock inspections, and support of regulatory inspections
Manage deviation, CAPA, and change control activities related to PSPV processes, including investigation support, documentation, and effectiveness checks
Monitor changes in pharmacovigilance regulations and guidelines and support implementation of required procedural or training updates
Support activities for the review, update, and ongoing maintenance of the Pharmacovigilance System Master File (PSMF), including coordination of routine reviews and contribution 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, including FDA, EMA, and ICH requirements
Experience with Quality Management Systems (e.g., Veeva or similar systems) are a plus
Strong organizational, documentation, and attention-to-detail skills
Effective written and verbal communication skills with the ability to collaborate across functions and with external vendors
Education and Experience
Bachelor's degree in life sciences, healthcare, or a related discipline; advanced degree (e.g., RN, BSN, PharmD) preferred
Minimum of 5 years of experience in Patient Safety/PV with 2+ years of related experience in PV compliance, standards, training, or quality system activities
Experienced in managing quality events (deviations, CAPAs, change controls)
Inspection/audit support experience and project management skills preferred
The pay range that the Company reasonably expects to pay for this headquarters-based position is $160,000 - $200,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
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Benefits
Health insurancePaid time off
Additional Information
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.
Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.
Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com .
The Manager, Patient Safety & Pharmacovigilance (PSPV) Compliance, Standards, and Training is responsible for supporting and managing activities for the execution and day-to-day oversight of PSPV compliance activities, including metrics/KPIs, maintenance of procedures, training programs, and quality system processes supporting both investigational and marketed products. This role partners closely with PSPV sub-functions, Quality Assurance, Clinical, Regulatory, and external vendors to ensure ongoing regulatory compliance.
Corcepttherapeutics · Redwood City, CA