Every company that holds a marketing authorization is responsible for the safety of its products once they reach patients. Good pharmacovigilance practice (GVP) guidelines, including those applied in Egypt and across the Arab region, ask the company to name one person who answers for that responsibility: the Qualified Person for Pharmacovigilance, or QPPV.
What the QPPV is responsible for
The QPPV oversees the pharmacovigilance system as a whole. That means making sure adverse events are collected, assessed and reported on time, that the safety profile of each product is kept under review, and that emerging signals are detected and acted on.
The QPPV also keeps the Pharmacovigilance System Master File (PSMF) accurate and up to date, has oversight of risk management plans and periodic safety reports, and acts as the single point of contact for the health authority, including during inspections.
In-house or outsourced?
Larger companies often appoint a QPPV from their own staff. Many others, including multinational companies without a local office, appoint an external QPPV or local safety responsible through a specialised provider. The obligations are the same either way; what changes is who carries the day-to-day workload.
When you outsource the role, look for a provider with a deputy in place, a validated safety database, documented procedures and a track record of audits and inspections. Insight provides local QPPV and deputy services as part of its pharmacovigilance outsourcing, supported by the Vigipx safety database.