Coordinate the tracking and distribution of adverse event reports (investigational and marketed products) Book adverse events in the safety database Maintain internal record systems Provide status
Coordinate the tracking and distribution of adverse event reports (investigational and marketed products) Book adverse events in the safety database Maintain internal record systems Provide status
, Beurteilen und Genehmigen von Deviation-Reports (Abweichungsberichte), CAPAs und Changes in der entsprechenden IT-Anwendung (TrackWise) Review und Genehmigung von SOPs und anderen GMP-Dokumenten
biometrician in the study-implementing teams of the clients Creating analysis plans Carrying out and / or monitoring the analyzes Cooperation in the report preparation Development of programs for the
systems, tools and reports Create and maintain centralized project/team work-spaces, including document creation and/or maintenance Assist with effective communication and information sharing via
Lead and/or contribute to the development of the clinical study database and all components in collaboration with the Study Data Manager who provides the core specifications Development of reports
protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management
management activities including, including respective documentation and drug safety reports Contributing to risk management activities including preparation and maintenance of CCDS, labeling document
writing clinical publications, expert reports and other regulatory documents such as PBRER and DSUR, etc Medical affairs manager
in DMPK, clinical and study management sub-teams Review protocols and guide project teams in all aspects of bioanalytical work required for the project Review data and reports for regulatory submissions