Pharmacovigilance services across international markets

Makromed provides pharmacovigilance services to pharmaceutical manufacturers, marketing authorisation holders, distributors and local affiliates. We support projects in Azerbaijan, Uzbekistan, Georgia, India and Russia through central coordination aligned with the requirements of each country.

The service scope may include pharmacovigilance system setup, coordination of a local responsible person, individual case safety report management, scientific literature monitoring, periodic safety reporting, RMP and PSMF preparation, safety signal management and regulatory submission support. The scope is defined according to the product portfolio, registration status, target countries and the company's operational needs.

The international website makromedglobal.com presents Makromed services for companies operating in one or more markets. A coordinated approach provides visibility of activities for each product and country within one project.

Primary button: Discuss your pharmacovigilance project

Secondary button: Request a proposal

What pharmacovigilance covers

Pharmacovigilance covers the collection, assessment, documentation and follow-up of information concerning the safety of medicinal products. Its purpose is to identify adverse events, emerging risks and changes to a product's safety profile in a timely manner, while meeting applicable regulatory obligations.

An effective pharmacovigilance system connects safety information sources, responsible persons, product calendars, individual case safety reports, literature monitoring results, periodic reports, risk management documents, correspondence with competent authorities and open actions. Makromed helps organise these elements within one controlled system.

Complete pharmacovigilance service package

Pharmacovigilance system setup

At the start of a project, we assess the company structure, product portfolio, countries in scope, safety information sources, allocation of responsibilities and key reporting dates. If a system is already in place, we identify gaps and elements that require updating. For a new project, we establish the working framework based on the agreed service scope.

Support may include defining responsibilities, mapping information flows, developing an obligations calendar, maintaining contact details, setting escalation rules, preparing required forms and recording open actions. The result is a clear framework for monitoring pharmacovigilance obligations by product and country.

Local responsible person and country coordination

Depending on the requirements of the relevant market and the agreed scope, we support the arrangement of an LPPV, QPPV or local pharmacovigilance contact function. We can also provide operational support to a responsible person already appointed by the company.

The service covers the allocation of duties, deputy arrangements, maintenance of contact details, oversight of local activities and deadlines, receipt of local safety information, coordination of responses to regulatory questions and the connection between the company's central system and local requirements. In multicountry projects, open items and upcoming actions are consolidated in one plan.

ICSR and adverse event management

Makromed receives safety information from agreed sources and verifies whether the minimum criteria for a valid individual case safety report are available. Duplicate checks are performed, and follow-up is coordinated when essential information is missing.

The agreed scope may include case classification, seriousness and expectedness assessment, medical coding support, narrative preparation, quality control, submission deadline tracking and archiving. Sources may include spontaneous reports, scientific literature, distributors, patient support programmes and other agreed channels.

Scientific literature monitoring

We develop a search strategy covering brand names, active substances and relevant synonyms. Searches are conducted at the agreed frequency across selected local and international scientific sources.

Results undergo primary and, where required, secondary screening. Potential ICSRs and safety signals are identified for further assessment, duplicates are excluded and full-text publications are obtained when needed. Sources, search parameters, assessment decisions and follow-up actions are documented in a traceable report.

DYTH PSUR and PBRER preparation

For DYTH, the Periodic Safety Update Report and the Periodic Benefit Risk Evaluation Report, we define the data sources, responsible contributors, data lock point, document structure and review schedule. The calendar reflects the product, registration status and applicable reporting timelines.

Support may include the data collection plan, registration and sales information, ICSR summaries, literature and signal results, an overview of risks and completed actions, benefit-risk evaluation, coordination of medical and regulatory sections, quality control, preparation of the submission package and status tracking.

RMP preparation and maintenance

The Risk Management Plan is prepared and updated in line with the product's safety profile, registration status and the requirements of the relevant market. It may cover important identified and potential risks, missing information, routine and additional pharmacovigilance activities, and risk minimisation measures.

Where required, we support local annexes, monitoring of agreed measures and documentation of effectiveness evaluations. RMP content is aligned with current safety data and related regulatory materials.

PSMF preparation and maintenance

The Pharmacovigilance System Master File describes how the pharmacovigilance system is organised and how responsibilities are assigned. Makromed helps prepare and maintain information on responsible persons, data sources, information flows, activities, the product portfolio, databases and software, performance indicators and local annexes.

The responsibility map and related sections are updated when products, countries, contacts or system elements change. This keeps the description aligned with the pharmacovigilance model in actual use.

Safety signal management

Potential signals may be identified from ICSRs, scientific literature, periodic reports, regulatory communications and other sources. We support signal documentation, validation, prioritisation and medical or scientific assessment.

For each signal, the basis of the decision, required follow-up, responsible parties and status of open actions are recorded. Where relevant new data are identified, the potential effect on the product's benefit-risk profile and product information is also assessed.

Regulatory submissions and responses to official enquiries

We coordinate pharmacovigilance documents for submission, check package completeness, address administrative requirements and track timelines and status. Format, language and package content are determined for the relevant country and document type.

When an official enquiry is received, Makromed helps organise the source data, draft the response, coordinate internal review and monitor the applicable deadline. Submitted materials, authority decisions and follow-up actions are recorded in the project history.

System transfer and continuity

When an established project is transferred, we organise the product and country lists, current status, open ICSRs, upcoming periodic report dates, RMP and PSMF status, literature monitoring history, planned regulatory submissions and outstanding actions.

The transition plan defines the sequence of activities, participant responsibilities and initial priorities. This helps maintain pharmacovigilance continuity and reduces the risk of missing an obligation during a change in operating model or service provider.

Countries where services are provided

• Azerbaijan
• Uzbekistan
• Georgia
• India
• Russia

Makromed software and client portal

The Makromed client portal brings registration status, pharmacovigilance project status, DYTH, PSUR and PBRER dates, RMP progress, PSMF status, literature monitoring results, pending documents, open tasks and upcoming deadlines into one view.

Depending on the agreed project, the platform supports document exchange, notifications, status reports, activity history and access to submitted materials. The client can see both the final deliverable and the current status of the work leading to it.

The software complements the work of Makromed specialists and helps centralise information across products and countries. This is particularly useful for companies managing several markets, reporting calendars and parallel activities.

Why companies choose Makromed

• Pharmacovigilance services in Azerbaijan, Uzbekistan, Georgia, India and Russia
• Unified coordination for projects covering several countries
• A complete package or selected individual services
• Pharmacovigilance and medicinal product registration expertise within one team
• A central calendar for documents, tasks and deadlines
• Online access to project status through the Makromed client portal
• Support tailored to the company's products, markets and internal resources
• A service scope that can expand when new products or countries are added

Discuss your pharmacovigilance project with Makromed

If your company needs a pharmacovigilance system for a new market, local coordination in a supported country, preparation of a specific document or central oversight of obligations across several products, contact Makromed. We will review the initial information and propose a service scope that fits the project.