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Pharmacovigilance PDF Print E-mail
With the regulations in pharmacovigilance becoming more stringent, the pharmaceutical industry is facing an increased demand for patient welfare and safety. Companies need to collate all the vital safety information about their products to meet these regulations.

Good Pharmacovigilance Practices (GPvP) have to be ensured by the companies and are absolutely necessary for the safety of patients and for marketing authorization.

Our pharmacovigilance outsourcing services are aimed at providing our clients with cost effective, knowledge based solutions to their needs. 

MedHimalayas offer integrated Drug safety solutions and consulting services.

 

 

  • European Qualified Person for Pharmacovigilance (QPPV) services
  • Strategic planning
  • Clinical protocol program development
  • AE and SAE logging, data entry, tracking, using tracking databases
  • Adverse Events and Serious Adverse Events case processing
  • MedDRA and WHODRL coding
  • Serious Adverse Events narrative writing
  • Safety medical assessments by the physician
  • Generation of forms - CIOMS/Medwatch
  • Expedited reporting according to regulatory requirements
  • E2B electronic reporting format generation
  • Literature search and reviews
  • Management of follow-up cases
  • Notification of Suspected Unexpected Serious Adverse Reaction (SUSARs)
  • Periodic Safety Update Reports (PSUR) and Annual Safety Update Reports (ASUR) preparation
  • Signal detection and Benefit-risk assessment
  • Training in pharmacovigilance to the staff
  • Compliance monitoring and QC checks
  • Archiving
  • Full Data back up support
  • Medical Information Services
 
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