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. The Department consists of 27 full time employees with long experience in Pharmacovigilance services. 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 60 active contracts ranging from small local companies to large international cooperations providing local pharmacovigilance services but also global coverage.

Pharmacovigilance (post-marketing & clinical trials operations)

  • Provision of local QPPVs
  • Management of ADRs/AEs/SAEsand other relevant safety information
  • Preparation and submission of Aggregate Safety Reports (PSURs, PBRERs, ACOs, DSURs)
  • Monitoring of Product Safety (Signal detection, Risk benefit assessment)
  • Provision of EU QPPV and Deputy and development of PSMF
  • Local and Global scientific literature review
  • Provision of a validated safety database
  • Preparation of RMPs and Material for Risk Minimisation Activities
  • Setting up (writing and/or review) of Standard Operating Procedures
  • Pharmacovigilance Audits/Inspections participation
  • Writing and/or reviewing of Safety Agreements
  • Storage and protection of PV records
  • PV & Clinical Safety training/Inspection Readiness Training / Training of sales force for newly launched drugs/New PV officers
  • Conduction of PV Audits to contractual partners

Medical Device Vigilance

  • Set up of a MDV system
  • Collection, investigation, assessment and reporting of medical device incidents
  • Preparation of Periodic Summary Reporting, Field Safety Corrective Action and Field Safety Notice


  • Responsible person & Post Marketing surveillance
  • Reporting of SUEs and Safety Assessment