0 - 2 years
0 Lacs
Posted:6 days ago|
Platform:
On-site
Full Time
Perform case intake, triage, and processing of Individual Case Safety Reports (ICSRs).
Review and validate adverse event reports from healthcare professionals, patients, and literature.
Enter and maintain accurate data in the safety database (e.g., Argus, ArisG, or equivalent).
Assess seriousness, expectedness, and causality of reported events.
Code adverse events and drugs using MedDRA and WHO-DD dictionaries.
Prepare and submit safety reports to regulatory authorities within compliance timelines.
Support aggregate safety reporting (PBRERs, PSURs) and signal detection activities.
Participate in quality checks, audits, and inspections as required.
Collaborate with cross-functional teams to ensure timely exchange of safety data.
Maintain awareness of current pharmacovigilance regulations and industry best practices.
CLARIWELLGLOBAL SERVICES LLP
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