Senior Specialist I, Patient Safety & Pharmacovigilance (Clinical Trial Safety Operations) Job at Corcept Therapeutics, Redwood City, CA

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  • Corcept Therapeutics
  • Redwood City, CA

Job Description

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.

Responsibilities

  • 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

Requirements

  • 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

Job Tags

Contract work

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