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- providing local contact person (LCP) and deputy of LCP according to the specifications defined by National Center for Public Health and Pharmacy, Hungary
- providing EU QPPV contact person and deputy of QPPV according to EU and Hungarian guidance; operating gloval pharmacovigilance system
- registration to Eudravigilance system; providing consultancy assistance to our partners
- management of suspected adverse reactions of registered medicinal products
- monitoring of the published literature by a contractual partner, search for suspected adverse drug reaction reports and other relevant drug safety related information
- compilation of Periodic Safety Update Report (PSUR) / providing consultative help for our clients in the compilation of the document
- compilation of Risk Management Plan (RMP) / providing consultative help for our clients in the compilation of the document
- implementation of local additional Risk Management Minimisation Measures
- help our clients in the planning, authorization, conduct of post-authorization studies, i.e. Post-Authorization Safety Study (PASS) and Post Authorization Efficacy Study (PAES)
- management of adverse events of development medicinal products
- compilation of Development Safety Update Report (DSUR) / providing consultative help for our clients in the compilation of the document
- continuous contact with the regulatory authority
- help clients in preparation and implementation of Authority audits, conduction audits/ providing consulting assistance to our partner companies in preparation for a regulatory inspection
- providing consultancy support to our partner companies on the quality assurance tasks concerning pharmacovigilance system
- conducting audits for our partner companies to periodically check whole system or the activities of subcontractors
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