Actelion Pharmaceutical LTD
2004 – on-going
- Quality management and validation Oracle Argus Safety system
- Overall CSV responsibility for Oracle Argus Safety
- Implementation of Electronic Submission Manager (ESM)
- Implementation of MedDRA re-coding utility, MedDRA upgrades
- CSV representation during MHRA audit
- Business consulting for data warehouse project BIRDS (Business Reports for Drug Safety)
- Business consultancy and CSV responsibility of PV tracking system implementation Smart Track
- Quality management of legacy data migration into Smart Track
Bencard Allergie GmbH
2008 – on-going
- GMP facility Audit
- Allergy Therapeutics Ltd, Worthing UK
- Audit Service Provider CRO
- BPI Service GmbH, Berlin D
Helsinn SA
2008 – 2013
- Development and implementation of a DSUR reporting tool for Oracle Argus Safety
- Development and implementation of a tracking and KPI tool for Oracle Argus Safety
- Business consultancy and CSV responability for Oracle Argus Safety upgrades v3.0.2 to v4.2 and v4.2 to v7.0.1.1
- Implementation of MedDRA re-coding utility; MedDRA upgrades
- Data cleaning and consistency verification of Oracle Argus Safety database
- Alignment of business process to fit Oracle Argus Safety capabilities
- Implementing E2B reporting capabilities
Astellas Pharma Europe BV
Astellas GmbH
2005 – 2013
- Internal global Oracle Argus Safety system audit
- European CSV responsibility for global Oracle Argus Safety upgrade project v2.0.2 to v4.2 (USA, EU, JP)
- CSV responsible for E2B submission rollout Oracle Argus Safety electronic submission manager
- Audit of Software Provider
- Cenduit, Bangalore IND
- CRF Health; Helsinki FIN
- Tessella plc; Abingdon UK
- Firecrest Clinical; Corbally Limerick IRL
- Softscape; Wayland USA
- Plateau; Arlington USA
- CPA Software Solution; Paris F
- MediData Systems, New York USA
- TEAMworks / TrialLink, Singapore
- Manual Master, Pappendrecht NL
- Audits of Data Management CROs
- Metronomia, München D
- MediData GmbH, Konstanz D
- Pierrel Research Europe GmbH, Essen D
- SGS Life Sciences Services, Mechelen B
- HPR Dr. Schaffler GmbH, Aschheim-Dornach D
Micromet AG
2010 – 2011
- Quality management global PV system
- Audit of Software Provider
- ARIS Global; Bangalore IND
Fresenius Biotech GmbH
2007 – 2011
- Audits of Data Managements CRO
- Averion, Allschwil CH
- Zentrum Klinische Studien ZKS, Freiburg D
- Business consulting, safety system integration and validation
Novartis Vaccines and Diagnostics GmbH & Co.
2007 – 2009
- Business consultancy for integration of business unit
- Quality management and validation of Oracle Argus Safety system upgrade
- Data migration of legacy data into Oracle Argus Safety
- CSV responsibility
Novo Nordisk A/S
2003 – 2009
- Product and license re-configuration in Oracle Argus Safety
- Business and validation support for Oracle Argus Safety system upgrade
- Definition of configuration management process for Oracle Argus Safety, including SOP and change request forms
Sandoz International GmbH
2005 – 2008
- Project Management and CSV responsible for legacy data (Hexal, BSM) migration and business integration into Oracle Argus Safety
Novartis Pharma AG
2000 – 2007
- Project quality manager for global document management system (DMP)
- Project quality manager for legacy data migration into Oracle Argus Safety
MediGen AG
2005 – 2007
- Audit Service Provider CRO
- imphar AG, Berlin D
- Internal PV audit: Assessment of business processes and validation status of drug safety system
Sankyo Pharma GmbH
2005 – 2007
- CSV responsibility for implementation of E2B submission module Universal Connector and AGXchange in connection with ClinTrace safety database
F. Hoffmann-La Roche Ltd
2004 – 2005
- Business process re-engineering for PSUR compilation
- Documentation of PSUR process incl. SOP writing
Schering AG
2001 – 2003
- CSV support for Oracle Argus Safety initial implementation
- CSV support and business analyst for legacy data migration into Oracle Argus Safety using Argus CaseLoader utility
Fujisawa GmbH
2001 – 2003
- CSV support for Oracle Argus Safety initial implementation
- Quality system implementation and user training
- Legacy data migration into Oracle Argus Safety
Novartis Consumer Health
2001 – 2002
- Business consultancy and CSV responsible for business integration and legacy data migration into Oracle Argus Safety
Novartis Ophthalmics AG
2001 – 2002
- Business consultancy and CSV responsible for business integration into Oracle Argus Safety