Patient Safety and Pharmacovigilance Operations Specialist

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.

This role supports Patient Safety and Pharmacovigilance (PSPV) Safety Operations activities in the postmarketing (PM) and clinical trial (CT) setting. The role is primarily responsible for the daily management of shared PSPV mailboxes and other safety intake channels, ensuring incoming communications are reviewed promptly, potential safety information is identified, and items are appropriately documented, routed, tracked, and escalated in accordance with established procedures and regulatory timelines.

Responsibilities:

• Monitor and manage assigned PSPV shared mailboxes and intake channels, ensuring timely review and disposition of incoming reports and communications
• Perform initial review/triage of incoming information to identify potential adverse events (AEs), serious adverse events (SAEs), product quality complaints (PQCs), special situations, and other safety-relevant information
• Identify potential Individual Case Safety Reports (ICSRs) and ensure information is routed to the appropriate case-processing team or workflow within required timelines
• Categorize, assign, route, file, and archive mailbox communications according to established procedures
• Prioritize and escalate serious, urgent, medically significant, or time-sensitive safety information as required
• Perform routine reconciliation of PSPV mailboxes and intake channels/sources to confirm potentially reportable information has been appropriately identified, received and processed
• Support the development of training materials
• Track and archive safety-related training for internal teams and vendors
• Assist with audits, regulatory inspections, and inspection-readiness activities by providing intake records and supporting documentation, as needed