Pharmacovigilance Services for Medicinal Products:
– Qualified Person Responsible for Pharmacovigilance (EU-QPPV and Local QPPV);
– Pharmacovigilance System;
– Medical and scientific literature screening;
– Periodic Safety Update Reports (PSUR);
– Risk Management Plan (RMP);
– Preparation of Safety Data Exchange Agreements (SDEA);
– 24-hours telephone testing;
– Training in pharmacovigilance;
– Translation of documents.
All medicines can cause unwanted side effects in some people. Many side effects are mild, but some can be serious and life-theatening. Occasionally, side effects can appear after a person has stopped taking a medicine.