Pharmacovigilance (PV) is a regulatory obligation, but in practice it is often treated as a secondary function until something goes wrong. The Therapeutic Goods Administration (TGA) continues to identify recurring deficiencies across sponsors of all sizes, particularly within listed medicines and complementary products. These findings are rarely due to a lack of intent; more often, they reflect gaps in systems, oversight, and practical implementation

Pharmaceutical companies often rely on various external vendors to support activities such as adverse event reporting, safety data processing, and regulatory intelligence. This responsibility extends beyond traditional vendors to include entities such as social media influencers and market research organisations (MROs) that may receive and process safety information. Ensuring that these vendors meet rigorous standards for quality, compliance, and data integrity is essential for maintaining the safety and efficacy of medicinal products.