Clinical Trial Consultant II
Job Summary
Working remotely on a contract basis, the Clinical Trial Consultant II will be responsible for case processing and quality control of clinical trial ICSRs and postmarket case processing from sanctioned countries.
Key responsibilities
- Triage, intake, case entry, and quality control of ICSRs from company-sponsored studies, including narrative writing and MedDRA coding
- Independently manage assigned cases to ensure timely delivery to internal stakeholders and compliance with regulatory reporting requirements
- Collaborate with Data Management to resolve reconciliation issues between clinical and safety databases
Required qualifications
- Bachelor's degree in a science or healthcare-related field
- 4+ years of experience in pharmacovigilance
- Knowledge of global and local safety regulations, including FDA, ICH, and EU guidelines
- Experience in ICSR processing using safety database systems such as ArisG, Argus, and Veeva
- Strong understanding of medical concepts and terminology
Complete Job Description
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