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
