The Pharmacovigilance department of Pharmassist has achieved through the work of its highly experienced and motivated people to deliver high quality services to its clients and be well ahead of the continuous changes in the field. Pharmassist’s pharmacovigilance system has been audited several times over the last couple of years by International Pharma Companies/Contract Safety Surveillance Organisations with successful outcomes (no critical findings).  Currently we have over 50 active contracts ranging from small local companies to large international cooperations providing local pharmacovigilance services but also global coverage.


  • Provision of EU QPPV and local QPPV with 24h availability
  • Management of ADRs/AEs and other safety relevant information
  • Preparation and submission of Aggregate Safety Reports (PSURs, PBRERs, ACOs, DSURs, p-SUSARs)
  • Monitoring of Product Safety (Signal detection, Risk benefit assessment)
  • Preparation of PSMFs, RMPs and material for Risk Minimisation Activities
  • Local and Global scientific literature review

Medical Device Vigilance

  • Set up and maintenance of complete MDV system, for all types of devices
  • Collection, investigation, and assessment of medical device incidents
  • Submission of medical device incidents to Competent Authorities
  • Storage and protection of medical device incidents records
  • Preparation of Periodic Summary Reporting, Field Safety Corrective Action and Field Safety Notice


  • Responsible person
  • Set up of a complete post-marketing surveillance of Serious Undesirable Effects
  • Reporting of Serious Undesirable Effects
  • Cosmetic products safety assessment (safety report)