DELTENRE Fabian (EFOR-CVO)
Computer system validation :
- Pharmacovigilance systems
- R&D Robotics & image analysis systems
- Custom developed systems (GAMP 5)
- Laboratory equipment systems
- Clinical trials management systems
- SoftmaxPro systems
- Excel systems (with VBA)
- Statistical systems (R and SAS)
Data Integrity :
- Implementation of DI programs following authority guidance
- DI verification and implementation on CS
- DI training
Project Management :
- Definition of project planning
- Identification of project risks
- Budget and resources management
Diplôme(s) – Qualification – Certification
Master in Computer Sciences (Operational Research).
Master in Biological Sciences.
Experience in pharmaceutical industry and biopharma (R&D, pharmacovigilance, clinical studies).
Expertise in Computer System Validation (CSV) and data integrity.