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Pharmacovigilance

Pharmacovigilance (PV) is the "science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem".1

An adverse effect or adverse drug reaction (ADR) is defined by the Medicines and Healthcare products Regulatory Agency (MHRA) as "an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs, and is suspected to be related to the drug. The reaction may be a known side effect of the drug or it may be new and previously unrecognised".2

Via a strategic partner, Global Regulatory Services (GRS) can provide companies with a complete Pharmacovigilance Package which includes the following:

  • Trained pharmacovigilance personnel with international experience (including senior safety physicians)
  • Qualified Person (QP)
  • Assistance with Health Authority inspections
  • PSUR writing; Clinical Expert Reports; Risk Management Plans and Pharmacovigilance Plans for licence submissions
  • Auditing of pharmacovigilance activities (including affiliates, distributors and for due diligence purposes)
  • Weekly literature searches for Adverse Drug Reactions (ADRs)
  • International expedited reporting (including electronic reporting)
  • Safety reviews and signal detection
  • Core safety preparations
  • Compilation of a portfolio of Frequently Asked Questions (FAQs) etc using a validated medical information database
  • Client access to a validated safety database
  • Training for all levels of Pharmacovigilance

Please contact us with your specific regulatory compliance requirements.

  1. Source: World Health Organisation (2004) WHO policy perspectives on medicines – pharmacovigilance: ensuring the safe use of medicines. Geneva: WHO.
  2. Source: Medicines and Healthcare products Regulatory Agency (MHRA)