Pv Scientist

Feladatok: Identify, interpret, and extract adverse event information from source documents.Receive, triage, and book‑in ICSRs from email and other sources.Process non‑serious and serious AE/ADR cases in global safety databases in line with SOPs.Perform seriousness assessment, duplicate checks, and drug‑event relationship entry.Create clear, complete medical narratives and ensure medical plausibility and consistency.Translate trade names to INN and code adverse events using MedDRA.Submit ICSRs to global authorities within regulatory timelines. Elvárások: Identify, interpret, and extract adverse event information from source documents.Receive, triage, and book‑in ICSRs from email and other sources.Process non‑serious and serious AE/ADR cases in global safety databases in line with SOPs.Perform seriousness assessment, duplicate checks, and drug‑event relationship entry.Create clear, complete medical narratives and ensure medical plausibility and consistency.Translate trade names to INN and code adverse events using MedDRA.Submit ICSRs to global authorities within regulatory timelines.Klinikai kutató

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