The ever-evolving landscape of global health crises, technological advancements, and regulatory changes underscores the importance of business continuity in pharmacovigilance operations. This article explores the concept of business continuity in pharmacovigilance and outlines strategies for achieving it in the Australian context

In pharmacovigilance, where data integrity, security, and accessibility are critical, the IT department serves as an essential partner to ensure compliance and smooth operations. IT involvement spans across several key areas, including secure data exchange, system transfers, business continuity planning, and robust system security.

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.

Organised Data Collection Systems (ODCS) are essential to pharmacovigilance, ensuring systematic, comprehensive, and reliable data collection to monitor and improve drug safety.

In the pharmaceutical industry, ensuring the safety and efficacy of drugs is paramount. This responsibility is shared between various departments, with Quality Assurance (QA) and Pharmacovigilance (PV) playing crucial roles. While Pharmacovigilance focuses on monitoring and assessing adverse drug reactions, the QA department ensures that the processes involved in drug production and monitoring meet stringent quality standards. The intersection of these two functions is critical for maintaining drug safety and regulatory compliance.

Not all sunscreens are created equal, and ensuring their safety and efficacy falls under the purview of the Therapeutic Goods Administration (TGA).

Event coding in PV stands out as a critical process. A systematic and standardised approach to coding adverse events and medical terms is essential for efficient signal detection, risk management and regulatory reporting.