Profile Sven Harmsen  - Senior Consultant


In total 18 years experiences servicing the pharmaceutical industry

Visiting lecturer (Lehrbeauftragter) at the University of Bonn for the "Master of Drug Regulatory Affairs" course since January 2009
more information at:  http://www.dgra.de/studiengang/studiengang.php



6 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)