We are providing experienced local PV contact person and a Deputy residing at the
local level and if needed PV project Manager to be dedicated for the client project

  • Provision of a main point of contact and deputy local person responsible for
    Pharmacovigilance
  • Notification in front of the Bulgarian Drug Agency
  • Responsible for post marketing monitoring of portfolio of products in various therapeutic
    areas including well-established products but also innovative products (such as Advance
    Therapeutic Medicinal Products, biological products, antisense nucleotides and others
    targeted products)
  • Responsible as Local person responsible for Pharmacovigilance services during Patient
    assistance / support programs
  • Collect, process and translate safety relevant information and Local Individual Case
    safety reports from Bulgarian to English within 24 hrs upon receipt of informatio
  • Local literature screening process (including translation of articles from Bulgaria to
    English, provide timely reports to clients in alignment with the set operating procedures
    and defined project KPIs
  • Pharmacovigilance intelligence screening (including weekly screening of Bulgarian Drug
    Agency website and Ministry of Health for relevant legislation updates and safety
    information concerning clients’ products)
  • Communication with national Health Authority
  • Participation of PV-relevant audits and inspections if required.