PharmacoVigilance Support

Pharmacovigilance (PV) also known as Drug Safety is the science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Once the medical drug is incensed for human use the  practice of monitoring its side-effects or Adverse Events (AE) starts.

MEDICEPTION provide full consultation and support towards PV:

  • Pharmacovigilance system Master file (Hosting a server)

  • Collection, Processing, Reporting of  individual case safety reports

  • Preparation and Submission of Periodic Safety Update Reports (PSURs)

  • Quality System management at organizations

  • Audit  and Inspection of PV system

    • Preparation of SOPs for checklists & Audits​

  • Submission of Risk Management Plan