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01.
Organisation and Management of the Company Pharmacovigilance System
- Pharmacovigilance System Master File (PSMF)
- Qualified Person for PV (QPPV) & Deputy QPPV
- Management of Safety Data-Base (ICSRs data entry, QC)
- Local Contact Person for PV
02.
Eudravigilance
- Handling of the Eudravigilance Data Base for ICSRs and XEVMPD (art. 57)
- Reporting of SUSARs arising from Clinical Trials
03.
Medical expertise for ICSRs/SUSARs, Signal Detection, Literature, aggregate reports assessment
04.
Literature Search
05.
Safety documents
- PSUR/PBRER
- RMP
- DSUR
- AdCO
06.
Support for Audits and Inspections
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