Professional pharmacovigilance and regulatory affairs services in SK & CZ
Bratislava, Slovakia

Pharmacovigilance Services

Pharmacovigilance SK, CZ & CEE region

Local Pharmacovigilance Representation Slovakia, Czech Republic & CEE region
We can fulfill all Marketing authorization Holder´s obligation in SK, CZ & CEE region including:

Notification of Local Safety Officer to the Competent Authority
Weekly monitoring of locally published scientific and medical literature
Local processing of Individual Case Safety Reports
National regulatory intelligence
Risk Management Measures local implementation
Controlled Access program Slovakia, Czech republic & CEE region
Local support in Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs) handling
Delivery of pharmacovigilance training to local Marketing Authorisation Holders personnel
Pharmacovigilance Audit and Inspection Services
Pharmacovigilance Standard Operation Procedures Set-up
24/7 availibility
European Qualified Person for Pharmacovigilance EU QPPV Services and Deputy EU QPPV.

The main responsibilities of the QPPV are the establishment and maintenance of the marketing authorization holders PV System and to have overview on the safety profile of the medicinal product.
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Contact

  • +421 907 115 206
    +421 918 567 646
  • office@njpharma.eu