The submission of periodic aggregate safety reports to regulatory authorities – such as development safety update reports and periodic safety update reports/periodic benefit-risk evaluation reports – is a cornerstone of pharmacovigilance during a medicinal product's lifecycle. These complex safety documents are authored at defined intervals and must meet strict submission deadlines to support the ongoing assessment and communication of a medicinal product's benefit-risk profile. Compiling these documents can be challenging and involves the analysis of various data source types from numerous stakeholders. To successfully author these documents, medical writers must demonstrate strong project leadership, regulatory knowledge, and the ability to interpret and summarise complex safety data. Medical writers can use the strategies and best practices outlined in this article to streamline the authoring process and ensure timely, compliant submissions.