Safety & PV Coordinator - Clinical Trial Case Processing (1 Year Experience)
Core
Process and track Individual Case Safety Reports (ICSRs) for clinical trials and post-marketing programs, ensuring data accuracy, regulatory compliance, and timely reporting.
Role type
Clinical Trial Case Processing Coordinator (Pharmacovigilance)
Builds
Safety databases, regulatory reports (expedited), and Trial Master Files (TMF)
Domain
Life Sciences / Clinical Research / Pharmacovigilance
Required skills
ICSR processing, MedDRA coding, literature screening, regulatory reporting, data entry, quality review, duplicate identification, TMF management
Preferred skills
Safety database systems proficiency, knowledge of clinical trial phases II-IV, GCP/GVP regulations
Technologies
Safety databases, Microsoft Office Suite, Visio, Team Share
Responsibilities
Enter and track ICSRs in quality systems; triage and evaluate ICSR data for completeness and regulatory reportability; code events, medical history, and concomitant medications; compile narrative summaries; manage queries and follow-ups; perform literature screening and MedDRA coding; validate and submit xEVMPD product records; identify and manage duplicate ICSRs; ensure document submission to TMF; maintain compliance with SOPs and global regulations.
Seniority
Entry-level to Junior, hands-on IC
