Company Record

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

 

Sartorius AG


2016 – on-going

  • Perform a review of the IT quality system for SAP based computerized systems
  • Review and assess the quality documentation for SAP based computerized systems

 

AMS Advanced Medical Services GmbH


2010 & 2016

  •  Initial and follow-up audit of Quadratek Data Solutions Ltd, the clinical data management solution provider for AMS

 

Astellas Pharma Europe BV
Astellas GmbH


2005 – 2015

  • 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 roll-out 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
    • Syneed MediData, Konstanz D

 

Bencard Allergie GmbH


2008 – 2014

  • 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 responsibility 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

 

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 Management CROs
    • 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

 

MediGene 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
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