An Adverse Event Is Not Always Obvious: A Practical Guide for Australian Listed Medicine Sponsors
For sponsors of listed medicines, pharmacovigilance does not begin when a report reaches the PV team. It begins when someone, somewhere in the organisation, first receives information about a possible adverse reaction.
That information might come through a customer complaint, an email to the sales team, a social media comment, a distributor or a conversation with a healthcare professional. It may not look like a conventional adverse event report, and the person receiving it may not realise that it requires further assessment.
This is where gaps in a sponsor’s pharmacovigilance system can emerge.
For Australian sponsors of listed medicines, including complementary medicines and supplements, having a process for collecting and managing safety information is essential. The challenge is ensuring that relevant information is recognised, documented and escalated, regardless of where it originates.
The Role of Medical Affairs in Pharmacovigilance
The Medical Affairs department plays a crucial role in ensuring the safety of medicines and therapies throughout their lifecycle. While traditionally seen as a bridge between clinical research and the commercial arm of a pharmaceutical company, Medical Affairs also has an essential function in pharmacovigilance (PV). This responsibility arises because of the department’s close contact with healthcare professionals (HCPs), patients, and key opinion leaders (KOLs), which makes it a critical source of post-market safety information.