Pharmacovigilance Veterinary Medicines
Pharmacovigilance and Drug Safety relate to understanding of signals and prevention of adverse events (possible side-effects) of a (veterinary) medicine. In industry, pharmacovigilance is the science of collecting information about potential drug-related adverse events to prevent unwanted side-effects of a (veterinary) medicine taken into account the risk-benefit balance of this medicine related to the animal, human and environment.
Our Service in Pharmacovigilance Veterinary Medicines
Become your Regulatory Contact person within the EU.
Become your EU Qualified Person for Pharmacovigilance (QPPV) or QPPV Deputy/ Back up.
Within veterinary medicines, available 24/7 for Marketing Authorisation Holder’s.
Become your External Pharmacovigilance or Regulatory Affairs Veterinary Consultant;
Prepare and perform Internal Audit´s on the Pharmacovigilance System of the company.
Set up a Detailed Description of Pharmacovilance System (DDPS/ PSMF).
Send in a Variation on change of EU QPPV or DDPS/PSMF.
Maintenance of the Pharmacovigilance System on-line by a secured environment (Norton). Register within EMA Account Management Portal.
Collecting data and notifying competent authorities in time on sending Expedited Reports of case reports/ ICSR's to Competent Authorities via EudraVigilance (Human and Veterinary) or to National Authorities outside the EU through a secured environment CESP or Eudralink. Certified EV data entry and XEVMPD.
Writing Periodic Safety Update Report's (PSUR’s) and other Safety Reports - Benefit/ Risk Evaluation Report’s. Worksharing PSUR's.
Training on location in pharmacovigilance veterinary wherein critical topics as;
Electronic AE Reporting in EVVET including narrative writing,
VedDRA/ MedDRA coding,
Causality Assessment writing,
ABON coding in Eudravigilance (Human and Veterinary),
Writing PSUR’s including CSDS, Excel Line Listing, tabulation generating
and Signal Detection according EU Guidelines.