Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine related problem.

Pharmacovigilance Objectives:

  • Preventing harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of marketing authorisation or from occupational exposure; and
  • Promoting the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public.

Pharmacovigilance is therefore an activity contributing to the protection of patients ‘and public health.

Main services:

  1. Preparation and update of Pharmacovigilance System Master File (PSMF)
  2. Preparation, update and submission of Risk management plan (RMP)
  3. Preparation and submission of Periodic Benefit Risk Evaluation Report (PBRER)
  4. Preparation of Addendum to Clinical Overview (ACO).
  5. Literature Screening
  6. Signal management
  7. Medical Writing
  8. Management of ICSRs.
  9. Pharmacovigilance Consultancy.