Marcus Stephan

•Creation of the Safety and Medical Management Plan• Serves as Lead Drug Safety Associate• Safety letter submissions to IRBs/ECs, investigational sites and Regulatory Authorities according to country-specific reporting guidelines/timelines • Processing of individual case safety reports (ICSRs) • Generation of accurate and well-written case narratives• Coding of diseases, adverse events, (MedDRA) and medication (WHODrug)• ICSRs entry into safety databases according to entry guidelines and query management

Datamanagement, Querymanagement, SAE processing(data entry, narrative writing), Study related Case Evaluation, Programming of query checks with SQL, Preparation and presentation of web based trainings for employee, Creation of databases

Management of revenue assurance, Case management, Coding of diagnoses and procedures, system administrator and first-level-support for employees of the Lister hospital, continuous reporting to the hospital management, creating of various statistics for the hospital management,