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

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)