why GLOBAL pharmacovigilance needs ai | chapter 2What Makes Good Pharmacovigilance Case Management?
Pharmacovigilance is an essential part of assuring that drugs and medical products are safe. However, to reliably protect both patient health and company reputation, it must not only be done but be done well.
So — what is good pharmacovigilance?
The right information is reported at the right time and fast
Timely, appropriate, fit-for-purpose reporting is crucial to assure patient safety and meet regulatory requirements. Reporting requirements can be very tight, with some regulators even mandating that AE reports are submitted within 24h.
Case processing is done in a standardized way
Standardization is essential to ensure quality, integrity, accuracy, and consistency across all markets and patient bases. By implementing standardized processes and systems, pharmaceutical companies can maintain uniformity in how data is collected, reported, and analyzed worldwide. This goes hand-in-hand with centralized working, which involves managing pharmacovigilance information from a unified, central point. Centralization ensures that all pharmacovigilance data remains consistent, accessible, and up-to-date regardless of time zone or location, thus facilitating seamless coordination and effective response to any safety issues that arise.
Workflows are efficient and cost-effective
Good pharmacovigilance practices balance speed, quality, and cost, contributing to overall organizational efficiency and effectiveness — a challenging but crucial task. Unfortunately, many companies spend more than necessary on pharmacovigilance case management by working in a responsive or ad hoc manner or by relying on disjointed or inconsistent region-specific workflows.
Systems are suitable for today’s globalized world
As pharmaceutical companies expand into new or growing markets worldwide, pharmacovigilance systems must be scalable and equipped to handle ICSRs in many languages and with a wide range of regional requirements. Crucially, this includes assuring that case reports are fully compliant with regulations that differ from market to market.