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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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