Pharmacovigilance
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Pharmacovigilance

Pharmacovigilance

We provide pharmacovigilance solutions at local level in Bulgaria and Romania

 

  • Appointment of local contact person for pharmacovigilance and deputy officer (24/7 service)
  • Weekly literature screening and translation services
  • Weekly monitoring of governmental websites, regulatory, and legal intelligence
  • Communication point for the NCA¹, local HCPs², patients, client’s sales force and QPPV³
  • Follow up of Individual Case Safety Reports
  • Pharmacovigilance trainings of client’s sales force
  • Support with DHPC⁴ and aRMM⁵
1. National Competent Authorities (NCA); 2. Health Care Professionals (HCPs); 3. Qualified Person for Pharmacovigilance (QPPV); 4. Direct Healthcare Professional Communication (DHPC); 5. Additional Risk Minimisation Materials (aRMM)

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