Pharmacovigilance Services

Pharmacovigilance Services

What is Pharmacovigilance?
Pharmacovigilance is a type of scientific and practical activity aimed at identifying, evaluating, understanding, and preventing adverse effects associated with the use of medicinal products.

The importance and necessity of Pharmacovigilance
Failure to comply with pharmacovigilance requirements may lead to the suspension of marketing authorization or cancellation of the registration certificate. This entails serious legal and financial risks for the company.

An innovative approach to Pharmacovigilance!
Makromed, relying on many years of experience, provides high-level pharmacovigilance services in accordance with local and international regulatory requirements.
As a leader in pharmaceutical software sector in Azerbaijan, Makromed offers effective management of pharmacovigilance processes.
With specially developed software, you gain the ability to monitor and control all processes related to medicinal products.
The legal requirements in the field of pharmacovigilance represent a complex set of rules that demand strict compliance. The Makromed team is always by your side to ensure full adherence to these requirements.

Scope of Pharmacovigilance services
• Appointment of a Qualified Person for Pharmacovigilance (QPPV)
We provide a qualified specialist who oversees the pharmacovigilance system and ensures timely and accurate safety data management in accordance with regulatory requirements.

• Preparation and implementation of the Pharmacovigilance System Master File (PSMF)
In accordance with legislation, we prepare and update the Pharmacovigilance System Master File (PSMF), which includes all information about the pharmacovigilance system. This document is the main source for monitoring activities and readiness for regulatory inspections.

• Literature Monitoring
Following Module VI of Good Pharmacovigilance Practices (GVP), we conduct weekly monitoring of medical literature related to medicinal products and ensure timely notification of adverse events to the regulatory authority.

• Preparation of Pharmacovigilance documentation
We prepare and implement key documents in accordance with GVP, such as Standard Operating Procedures (SOPs), Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs).

• 24/7 Pharmacovigilance support
We offer nonstop services for prompt responses to safety concerns and to maintain constant regulatory compliance.

• Communication with the National Regulatory Authority
We ensure timely and accurate submission of adverse event data and other pharmacovigilance information to the regulatory authority.

• Adverse event management
We carry out the collection, processing, analysis, archiving, and submission of adverse events to the competent authorities.

• Pharmacovigilance  system setup
We offer the development and implementation of an effective pharmacovigilance and quality management system in line with international standards.

• Audit preparation
With extensive experience in both local and international audits, we assist in preparing for internal and external audits of the pharmacovigilance system, evaluating compliance, and identifying areas for improvement.