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

The role

This role supports Patient Safety and Pharmacovigilance Safety Operations. The person will ensure quality, compliance, and timely reporting of safety information from company-sponsored clinical trials, Investigator-Initiated Studies, and expanded access/compassionate use programs.

What you will do

• Conduct quality review of clinical trial safety reports
• Support review and reconciliation of safety data
• Generate clinically relevant safety follow-up queries
• Review safety submission documentation
• Support oversight and monitoring activities of PV vendor(s)
• Support study-level safety operations activities and other PSPV projects
• 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

Required qualifications

• Applicants must be currently authorized to work in the United States on a full-time basis
• 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 Nurs

Nice to have

• 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
• Bachelor's degree in healthcare or life sciences
• degree such as RN or BSN, PharmD
• Working knowledge of FDA, EU and ICH guidelines for safety reporting for clinical trials

About the company

Corcept is focused on the science of cortisol. The company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists.