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 by ensuring the quality, compliance, and timely reporting of safety information from company-sponsored clinical trials, Investigator-Initiated Studies, and expanded access/compassionate use programs.

Responsibilities:

• Conduct quality review of clinical trial safety reports to ensure completeness and accuracy of safety data, consistency between source documentation, EDC and safety database records, and compliance with study-specific, internal and global regulatory requirements
• Support review and reconciliation of safety data to ensure investigator/site-reported information is accurately reflected in EDC and safety database
• Generate clinically relevant safety follow-up queries and collaborate with cross functional study teams and CRO to ensure timely resolution, escalating delays or missing information that impact case assessment, evaluation, or regulatory compliance
• Review safety submission documentation, e.g., expedited and aggregate reports, to ensure accurate, complete and timely reporting in accordance with global regulatory requirements
• Support oversight and monitoring activities of PV vendor(s) and provide feedback to support training and process improvement
• Support study-level safety operations activities and other PSPV projects, as assigned
• Assists in the creation/revision of department standard operating procedures and work instructions
• Development and delivery of training for safety related topics