Senior Specialist I, Patient Safety & Pharmacovigilance (Clinical Trial Safety Operations)
Corcept Therapeutics · Redwood City, CA
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Corcept Therapeutics seeks a Senior Specialist to support patient safety and pharmacovigilance operations for clinical trials. The role involves quality review of safety reports, data reconciliation, regulatory compliance, and cross-functional collaboration to ensure accurate and timely safety reporting across company-sponsored studies and expanded access programs.
What they're looking for
- Bachelor's degree in healthcare or life sciences; RN, BSN, or PharmD preferred
- 3 years of pharmacovigilance operations experience in pharmaceutical or biotechnology
- Proficiency with Argus safety applications and EDC systems such as Medidata RAVE
- Strong communication and cross-functional collaboration abilities
- Ability to manage multiple concurrent projects in fast-paced environment
- Up to 10% travel capability
What you'll be doing
- Conduct quality reviews of clinical trial safety reports for completeness and regulatory compliance
- Reconcile safety data between investigator reports, EDC systems, and safety databases
- Generate and resolve safety follow-up queries with study teams and contract research organizations
- Review and ensure accurate, timely submission of expedited and aggregate safety reports
- Support process improvement, training development, and audit preparation activities
Privacy & handoff
This role links to Corcept Therapeutics's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.