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Our aim is to provide assistance in:
- Processing adverse event reports, both spontaneous and from clinical
trials
- Processing of Product Technical Complaints on Medical Devices
- Preparation of Periodic Safety Update Reports
- Writing standard operating procedures and working practices
- Management of the pharmacovigilance process
- Continuous improvement and business process re-engineering to reduce
costs and insure compliance
- Audit of the Pharmacovigilance System
| Qualifications within the team include:
- Postgraduate Diploma in pharmacovigilance: University of Hertfordshire,
Hatfield
- Quality management and process control: Institute of Quality
Assurance
- Implementing ISO9000: Institute of Quality Assurance
- Project management skills
- Data processing and database management
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