0 - 2 years
0 Lacs
Posted:-1 days ago|
Platform:
On-site
Full Time
Collect, review, and evaluate adverse event (AE) data from various sources (clinical trials, literature, healthcare professionals, patients).
Perform accurate data entry of cases into safety databases (e.g., Argus, ArisGlobal).
Code events using MedDRA and WHO-DD.
Ensure timely processing of Individual Case Safety Reports (ICSRs).
Check case validity, seriousness, causality, and expectedness.
Identify duplicate cases and maintain data accuracy.
Perform narrative writing and case summarization.
Prepare and submit ICSRs to regulatory authorities within global timelines.
Support development of Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and DSURs.
Follow SOPs, regulatory guidelines (ICH, FDA, EMA), and company safety procedures.
Ensure audit readiness and maintain documentation accuracy.
CLARIWELLGLOBAL SERVICES LLP
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