Senior Specialist I, Patient Safety & Pharmacovigilance (Clinical Trial Safety Operations)

Corcept Therapeutics • Redwood City, CA

13d • $103,600 - $137,100 • Onsite

About The Position

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. Corcept has been focused on the science of cortisol for over 25 years, with commercial portfolio treatments for hypercortisolism and oncology. The company has discovered over 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is headquartered in Redwood City, California.

Requirements

• Working knowledge of FDA, EU and ICH guidelines for safety reporting for clinical trials

Nice To Haves

• Ability to work in a dynamic environment to meet patient and corporate needs
• Knowledge of Argus (or similar safety applications) and EDC systems (e.g., Medidata RAVE)
• Excellent communication and collaboration skills
• Ability to manage multiple projects in a fast-paced environment
• Able to travel for up to 10% of time
• Bachelor's degree in healthcare or life sciences - degree such as RN or BSN, PharmD is preferred
• 3 years of PSPV operations experience within a pharmaceutical or biotechnology company
• Candidates without prior PSPV experience will also be considered if they have at least 5 years of direct oncology clinical-study experience such as a Clinical Research Coordinator (CRC), Research Nurse, and/or Clinical Research Associate (CRA)

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
• Support process improvement initiatives and safety systems activities
• Support and participate in audits and inspections, including preparation activities

Benefits

• Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior