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No drug which is pharmacologically effective is entirely without hazard. There is no such thing as a safe drug. Safety is a relative concept, concerning the disease, the therapeutic alternatives and the individual perception and acceptance of risk. Pharmacovigilance challenge it's not just the early identification of drug utilization problems, but the rapid determination of its positive and negative effects for individuals and for communities.

Causality assessment of reported adverse events during drug exposure is crucial in Pharmacovigilance due to its implications in the benefit-risk evaluation of medicines.