What is Pharmacovigilance System Setup?
Pharmacovigilance (PV) is an important part of the pharmaceutical sector as it plays a crucial role in ensuring safety of medicinal products in their lifecycle. Marketing Authorization Holder (MAH) and clinical research organizations (CROs) are obliged to establish a compliant pharmacovigilance system in accordance with the requirements of global regulations. The aim is to identify, evaluate, learn, and avoid adverse drug reactions (ADRs) and other safety concerns
Global Regulatory Requirements for Pharmacovigilance Systems
Global health regulators, including the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), MHRA and WHO require pharmaceutical firms to establish and support a pharmacovigilance system as part of their marketing authorization. Such systems should adhere to standards like ICH E2E, GVP Modules (EU) and local requirements (e.g. CDSCO in India).
An established PV system makes sure that any safety signals that pertain to a medicinal product are realized sooner, assessed efficiently, and abated efficiently.
Key Components of a Pharmacovigilance System
Implementation of a pharmacovigilance system has several interconnected aspects. All of these elements are important in compliance and safety.
- Qualified Person for Pharmacovigilance (QPPV) The QPPV is a mandatory role in the EU and other regulated markets. This person holds overall responsibility for the PV system and must be permanently available to respond to safety concerns. QPPV gives adherence to reporting requirements and gives control over all safety related operations.
- Pharmacovigilance System Master File (PSMF) The PSMF is a comprehensive document elaborating the system and operation of the pharmacovigilance system. It contains data on the QPPV, organization, safety database, SOPs, compliance metrics and risk management activities. It should be maintained and be available to audit by the regulators.
- Adverse Event Case Management Pharma companies must have validated systems and procedures for collecting, processing, and reporting Individual Case Safety Reports (ICSRs). Such reports have to be provided to regulatory organizations such as EudraVigilance (EU) or FAERS (US) within some set timeframes. Case management involves data entry, medical coding, narrative writing and quality review.
- Signal Detection and Risk Management A core function of the PV system is continuous signal detection—the identification of new or changing risks based on available safety data. After confirmation of signals, Risk Management Plans (RMPs) and Risk Minimization Measures (RMMs) have to be updated.
- Periodic Safety Reporting Pharmaceutical companies are required to submit periodic safety reports such as:
- PSURs (Periodic Safety Update Reports) – EU
- PADERs (Periodic Adverse Drug Experience Reports) – US
- DSURs (Development Safety Update Reports) – during clinical development
- SOPs and Training All pharmacovigilance activities such as AE reporting, literature screening, signal management, and regulatory submissions are governed by Standard Operating Procedures (SOPs). PV personnel need to be continually trained to ensure quality and compliance.
The pharmacovigilance system has become a very strong tool in the pharmaceutical industry to protect the safety of patients and uphold the regulatory requirements all over the world. Since QPPV tasks extend to signal detecting and PSUR submissions, all the pieces should be in line with compliance requirements. Masuu Global partners with pharma companies to deliver end-to-end PV system setup and regulatory support.
