Sven Harmsen 
e-DRA Senior Consultant 

In total more than 20 years experiences servicing the pharmaceutical industry

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Visiting lecturer (Lehrbeauftragter) at the University of Bonn for the "Master of Drug Regulatory Affairs" course since January 2009
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more than 10 years at e-DRA Harmsen
• from January 2008 onwards implemented various EDMS, eSubmission, Regulatory Information and other R&D IT systems

6 years at Astellas Pharma / Fujisawa
• responsible for all European R&D  Document Management and Regulatory Affairs IT systems
• implemented and validated eCTD  publishing system
• implemented product database for Regulatory Affairs
• led Regulatory Affairs and Document Management IT merger integration
• contributed to global document management initiative
• contributed to Clinical Trial Management System implementation
• facilitated various process improvement initiatives within R&D 

4 years experience in the software industry servicing the pharmaceutical industry
• as Senior Systems Engineer at Documentum and at Open Text (Livelink)

2 years experience at CSC Consulting servicing the pharmaceutical industry

Other skills
• experienced with GAMP 5, PMI PMBOK, Prince2, ITIL, Catalyst, Isotec
• deep knowledge of eDMS (Documentum, Sharepoint) and eSubmission systems
• ability to bring structure to complex situations
• long experience managing global project teams with different cultural backgrounds
• ability to take over projects in difficult situations and manage successful  
• Master of Business and Computer Science (Diplom-Kaufmann)
• native German, fluent English (lived in USA and South Africa)