Astrid Helms

management of handling and reporting of all pharmacovigilance related matters used in clinical trials; process and review of SAE; coding of AE, indication, medical history and medications; narrative preparation; surveillance on SAE reporting and follow up; performing and coordinating data reconciliation between clinical and safety database; processing of clinical requests; contribution to the generation of periodic reports such as ASR/DSUR, IB updates, ICF, CRF, protocol; compliance with all regulato

process and review of SAE, entering and verification of SAEs in safety database, coding of AE, indication, medical history and medications, narrative preparation, surveillance on SAE reporting and follow up, handling emergency and regulatory unblinding, preparation of reports:ASR, interaction with appropriate regulatory agencies concerning safety related issues, performing and coordinating case report reconciliation with trial database. use of : MS-OFFICE, SAS, MedDRA, e-safety database

generating data management plans, DVP and conventions, validation of data, query genenration/resolution, coordinating and supervising the process of quality control of data, coordination of timelines, mailings, status reports, supervising and training of the CDA-team, preparation and active participation of sponsor meetings

Clinical Data Management, statistical analyses via SAS, SPSS, MS-OFFICE, CRF Design, quality control of study data, generating SOPs, pharmacovigilance experience