Profile Sven Harmsen  - Senior Consultant


In total more than 20 years experiences servicing the pharmaceutical industry


See also at www.linkedin.com/in/sven-harmsen-014463 for further details

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



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)