Pharmacovigilance expectations continue to evolve as health authorities place greater emphasis on patient safety, data quality, and proactive risk management. Companies can no longer rely on basic compliance; they must demonstrate robust, well-governed pharmacovigilance systems across the product lifecycle.
Strengthening a PV system starts with clearly defined roles, validated safety databases, and consistent case management processes. This is complemented by effective signal detection, timely regulatory reporting, and continuous oversight through audits and quality reviews. A mature pharmacovigilance framework not only meets regulatory expectations but also supports informed decision-making and long-term product sustainability.
