Telephone: +44(0)1353 774000
E-mail:enquiries@globalregulatoryservices.com

Pharmacovigilance

Pharmacovigilance 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 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.

¹World Health Organisation (2004) WHO policy perspectives on medicines – pharmacovigilance: ensuring the safe use of medicines. Geneva: WHO.

²Source: Medicines and Healthcare products Regulatory Agency (MHRA)

Return to GRS Regulatory Services List

Created and maintained by WSI

Global House, Painters Lane, Sutton, Ely,
Cambridgeshire, CB6 2NS, UK
Telephone: +44(0)1353 774000
E-mail: enquiries@globalregulatoryservices.com