Drug Safety Intern, Global Case Processing
Core
Support the handling of Individual Case Safety Reports (ICSR) in the GEHC Global Adverse Event Database (GAED) in compliance with regulatory standards.
Role type
Pharmacovigilance case processing intern
Builds
Global Adverse Event Database (GAED) case records
Domain
Healthcare / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Data entry, Quality review, MedDRA coding, Case narrative preparation, Follow-up letter generation, Regulatory compliance, Data archiving, Regulatory intelligence
Preferred skills
Knowledge of pharmacovigilance regulations and guidelines
Technologies
GAED, MedDRA
Responsibilities
Intake and triage of safety reports, Perform data entry and quality review, Conduct follow-up activities and close action items, Interface with internal stakeholders, Ensure archiving of safety data, Conduct Regulatory Intelligence tasks
Seniority
Intern