Pharmacovigilance

Pharmavigil services in the field of pharmacovigilance

The safety of your medicines is our priority. With our pharmacovigilance services, you will easily gain comprehensive knowledge of all risks and adverse reactions.

Our team

Pharmacovigilance helps to reduce potential risks that could harm patients, so it is crucial to leave the monitoring of the safety of your products in the hands of someone you can trust. Our pharmacovigilance department consists of a highly educated and professional team. We have all the necessary organizational and technical support for the needs of our clients, in accordance with the current legislation.

Our system

We have developed a system for carrying out pharmacovigilance activities at the local and global level, and an organizational structure that enables the full implementation of these activities. For individual approval holders / contractual partners, we can separately contract the entire service and/or individual tasks in the field of pharmacovigilance.

Appointment of the responsible person for pharmacovigilance

Each marketing authorization holder (MAH) is obliged to establish a pharmacovigilance system, prepare its detailed description and always have a responsible person for pharmacovigilance (QPPV) available.

Services:

  • EU QPPV and global pharmacovigilance
  • Local QPPV for Croatia, Portugal, Slovenia, Bulgaria, Czech Republic and Slovakia
  • Availability 24/7 hours
  • Complete or special package of services
  • Review of local and global medical literature
  • Validated security database
  • Establishment and maintenance of the pharmacovigilance system
  • Preparation and maintenance of the Master File on the Pharmacovigilance System (PSMF)
  • Medical writing (PSUR, RMP, PBRER, PADER, DSUR, SAR, Addendum to the Clinical Overview, etc.)
  • Overview of the drug’s safety profile and all questions regarding the safety of drug use
  • Acting in accordance with the established pharmacovigilance system and implementing necessary changes in the system
  • Contact for the inspection of the pharmacovigilance system
  • Electronic reporting of adverse reactions (E2B)
  • Monitoring of side effects: collection, processing, quality control, coding, classification, medical assessment and electronic reporting of individual cases of side effects within the legal framework (Individual Case of Side Effect Report (ICSR), tracking, duplicate detection)
  • Continuous monitoring of the drug’s safety profile (signal detection, assessment of the risk-benefit ratio, notification of the regulatory authorities about the drug’s safety profile)
  • Creation of a database of frequently asked questions (FAQ) for medical inquiries
  • Letter to health professionals (DHPC)
  • Risk minimization measures (MMR)

Literature review

A literature review is crucial to monitoring the safety profile of your product. We perform this service as part of pharmacovigilance and/or at the client’s request (retrospective literature review or as part of the medical writing service (periodic reports – PSUR)

With a proper and thorough review of the literature, you support quality monitoring of the safety of your medicines.

Medical and scientific journals are searched for information related to:

  • Adverse Event Individual Case Report (ICSR)
  • Published research containing new safety information
  • Publications from congresses or abstracts from expert meetings
  • Publications from registries, studies or drug information centers.

Review of literature for other purposes

If the client needs a literature review for a specific purpose, we can offer an optimal solution in accordance with specific requirements thanks to our professional knowledge.

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