Pharmacovigilance

Pharmacovigilance

Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.Pharmacovigilance projects are complex and require solid project management.There are many departments involved that often operate in silos, which results in an inability to communicate effectively and duplicated efforts. Organizations can have multiple locations, each with their own set of processes. All these barriers should be broken to allow for complete harmonization across all departments. It’s no longer enough being compliant with case processing alone. We encourage strategic thinking about Pharmacovigilance, which considers multiple factors and how they intersect. The high quality of provided pharmacovigilance consulting services is primarily ensured by the expertise and knowledge of ex-regulators as well as PV and Medical Information (MI) professionals forming Makromed company leadership.
 The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines. 
Starting from the 1st of July, a new law regarding with Pharmacovigilance system has came into force in Azerbaijan. According to the new legislation, each manufactured company, whose medicines are registered in Azerbaijan, must have a local Pharmacovigilance company for the handling of quality reports of registered products in Azerbaijan. MAKROMED LLC- a leading company with high professionalism in Azerbaijan, provides pharmacovigilance services in accordance with quality standards.
Some features of the pharmacovigilance service are listed below:
- Organization of pharmacovigilance system from scratch/modernization of existing system;
- Provision of qualified person for pharmacovigilance; 
- Access to shared contact center for drug safety reports receipt;
- Tailoring and implementation of pharmacovigilance system master file (PSMF)
- Intake, processing, analysis, archiving and submission to competent authorities of all drug safety reports;
- Development and regulatory submissions of periodic benefit-risk evaluation reports (PBRER) and periodic safety update reports (PSUR);
- Monitoring of pharmacovigilance regulations/recommendations;
- Literature screening for adverse events/other drug safety information ;
- Risk management plans (RMP) preparation/submission to competent authorities;
- Safety Signal Management;
- Aggregate report management;
- Adverse Event and Product complaint management;
- Individual case report;
- Safety database services;
- Literature monitoring and media monitoring;
The cost of pharmacovigilance work depends on the scope of rendered services and is determined individually.