Pharmacovigilance services

EudraVigilance (EV): Registration with EV; Responsible person for EV; EVMPD updates; Testing with national Competent Authorities (CAs).

AE and ADR handling: Receipt, initial assessment and following up with reporter;  Assessment of seriousness, expectedness and causality; Narrative writing; Reporting to Sponsor and entering into Sponsor’s or MAHs safety database; MedDRA coding; Source records maintenance.

Expedited submissions to CAs: Using EV Web trader or Sponsor’s /MAH safety database and gateway.

Other submissions:  Periodic safety update (e.g. ASRs, PSURs) submission to ECs/PIs/CAs; CIOMS creation; Expedited reports submission to ECs/PIs.

Standard Operation Procedures preparation and adaptation

Pharmacovigilance training

Literature search

Other services (Safety profile monitoring, Signal detection and review of new data, Risk-bene¬fit assessment etc.).