Pharmacovigilance

Whether you need project-related assistance or are seeking to outsource entire pharmacovigilance processes – our knowledgeable consultants will be there for you.
 
Pharmacovigilance quality system documentation is created for each client individually.
 
Contact us with confidence. Inquire about pharmacovigilance services at phv@pharmakos.hr.
 
If you are looking for local pharmacovigilance services in HR/B&H/CS/MN/MK, we are ready to:
  • Act as local contact person /deputy of local contact person for authorities
  • Perform local literature search (from any source of information about your medicines)
  • Perform local personnel pharmacovigilance trainings 
  • Process suspected adverse reactions (collection, translation and forwarding of the information, follow-up reports)
  • Reports submission to regulatory authorities
If you are looking for general post-marketing pharmacovigilance support, we are ready to:
  • Appoint EU QPPV 
  • 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 (worldwide and local)
  • Prepare periodic safety update reports (PSURs)
  • Prepare and update Risk Management Plans (RMPs)
  • Evaluate safety data
  • Prepare and regularly update product(s) reference safety information / Company core data sheet
  • Perform regulatory submissions monitoring
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