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i-Li Consulting

Pharmacovigilance system maintenance, process optimisation and validation

Pharmacovigilance Consulting & Services

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i-Li consulting offers consulting services and support for Pharmaceutical industry in investigating business situations, identifying and evaluating options for improving business systems and ensuring the effective use of IT systems in meeting the needs of the business.

Services

  • Analysis of business process and data flows, design and mapping of business process against standard,customized IT applications
  • Project Management (Safety Upgrade, Data Cleaning, Data Migration)
  • Single case processing
  • Writing of Clinical/PV SOPs
  • Computer system validation (URS, FRD, Qualifications)
  • E2B reporting testing to EMA and FDA
  • Quality Risk Management Plan & its control activities
  • Change and Configuration Manangement
  • System Maintenance SOPs
  • User training

 

Skills

Pharmacovigilance Business Analysis, Drug development process, GCP, GXP regulations and Pharma legislations and Directives. Validation of clinical computer system and writing of SOPs and working instructions.

 

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