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Pharmacovigilance

PharmaSich is a tailor-made and cost effective solution to outsource safety functions.

 

Our important mission is to help pharmaceutical companies:

  • Detect
  • Assess
  • Understand and
  • Prevent 

adverse effects or any other medicine-related problem. We offer a wide range of pharmacovigilance services to complete this mission.

Geographical Coverage

From the geographical standpoint we cover Ukraine and European Union (through our qualified partners).

Ukrainian Market

Ukraine is an ever more interesting pharmaceutical market of >40 million customers). This country has recently made the market access for the drugs registered in EU, USA, Japan and Switzerland easier (simplified procedure for obtaining local Market Authorisation has been adopted). That is causing the increase in the number of the medicines in the local market. Therefore, the demand of local QPPV services in Ukraine is expected to grow next few years.

 

PV services

Our PV services package includes:

  • Pharmacovigilance consulting
  • Post-Marketing Surveillance

 

Pharmacovigilance consulting

  • Regulatory Intelligence (local/international PV regulations; obtaining Marketing Authorisation in Ukraine)
  • Pharmacovigilance Trainings (PV awareness, international/local legislation, SOP trainings)
  • Setting up of Pharmacovigilance System “from scratch” (PV database, SOPs, Job Descriptions, training materials)
  • Safety Data Exchange Agreements
  •  Quality Assurance (PV audits, inspection readiness)

 

Post-Marketing Surveillance

  • Assignment of local Qualified Person for Pharmacovigilance (QPPV) with dedicated phone line, email and 24/7 contact availability
  • Safety Database & Pharmacovigilance System Master File (PSMF) maintenance
  • Signal management and processing of Individual Safety Case Reports (ICSRs)
  • Reporting of safety information to local Health Authorities
  • Preparation of safety reports ff(PSURs/PBRERs/ACOs etc)
  • Reconciliation of ICSRs with partners under Safety Data Exchange Agreements
  • Risk Management Plan production, review   vand maintenance
  • Local & Global Medical Literature Search with professional English, Russian, Ukrainian and German translations
  • Screening of pharmacovigilance-relevant website(s) and databases of Competent Authorities

 

Why PharmaSich?

  • Flexible outsourcing of safety functions 
  • Team of safety physicians and local QPPVs  with  broad therapeutic expertise for medical review and signal detection
  • Tailor-made and cost effective safety solutions for small and mid-size companies
  • Operational excellence

 

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