Services
pharmacovigilance
Advanced knowledge in pharmacovigilance, guidelines on ICH E2B (R3), GVP, GMP, AE reporting EMA/FDA, PSUR, DSUR, Signal detection and Risk management
projects
Analysis, design/planning and execution of project for pharmaceutical companies.
Technical and Process Consulting for Pharmaceutical companies, define company specific solutions
computer system validation
Computer System Validation for IT applications at GxP and non GxP environment. Pharmacovigilance system implementation und upgrades.
F.A.Q.
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VigiS3
VigilanceONE
PcVmanager
Empirica Trace
Computer System Validation after system implementation, system migration, system update, data migration, data cleaning. Change management planning and performing in Sandbox/ACC/Prod environment. Documentation with
VP, URS, RA, IQ, OQ, PQ, VS, and test scripts.
Gateway configuration and registration to Eudravigilance (EMA), MHRA and FDA.
MS Powershell
VM Tools, SharePoint, SAP Solution Manager, MS Project, WebEx, TeamViewer