Pharmacovigilance Services

Pharmacovigilance (PhV) is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medicines, biological products, herbals and traditional medicines with a view to:

  • Identifying information about potential new hazards.
  • Preventing harm to patients.

In EU the pharmacovigilance is regulated by the European Parliament and European Council Regulation (EU) No 1235/2010 and Directive 2010/84/EU, accompanied by the implementing regulation Commission implementing regulation No 520/2012.

JSC Sveikuva provides range of post-marketing pharmacovigilance (PhV), medicines or drug safety services for marketing authorisation holders:

If you are looking for local pharmacovigilance services in CEE countries:

We are ready to:

  • Act as local contact persons for authorities
  • Perfom local literature screening for adverse events (or any source of information about your medicines)
  • Perform local personnel pharmacovigilance trainings
  • Process suspected adverse reactions (ARs) (collection, translation and forwarding of the information, follow-up)

If you are looking for general post-marketing PhV support:

We are ready to:

  • Appoint QPPV (Qualified Person Responsible for Pharmacovigilance)
  • Establish medical affairs support
  • Register your company in EudraVigilance
  • Manage pharmacovigilance data
  • Process of case data
  • Prepare adverse reaction reports
  • Perform adverse events / reactions reporting to competent authorities
  • Enter product and safety data to EudraVigilance
  • Perform literature monitoring (world wide and local)
  • Prepare periodic safety update reports (PSURs)
  • Prepare and update RMPs (Risk Management Plans)
  • Evaluate safety data
  • Prepare and regularly update product(s) reference safety information/Company core data sheet
  • Perform regulatory submissions monitoring
  • Professionalism.
    We are specialists in this field and like our activity, so we can guarantee the quality of our work.
  • Competitiveness.
    Individual solutions for a competitive price.
  • Confidentiality.
    We appreciate the cooperation, maintain confidentiality and seek for a long-term partnership