Pharmacovigilance & Drug Safety

Receive, triage, and process adverse event reports from clinical trials, spontaneous reports, literature, and patient support programs. Code events using MedDRA, assess causality, and submit expedited reports (ICSRs) to regulatory agencies within mandated timelines — 15 days for serious unexpected events, 7 days for fatal/life-threatening.

Analyze aggregate safety data to detect new safety signals — disproportionality analysis across FAERS/EudraVigilance, periodic safety review, and signal evaluation from clinical trial databases. Prepare DSURs, PSURs/PBRERs, and safety sections of regulatory filings.