Pharmacovigilance involves the intake, processing, and evaluation of adverse events associated with pharmaceutical products, with the aim of enhancing understanding of their safety profiles and supporting the ongoing assessment of their benefit–risk balance. This article explores signal management in pharmacovigilance, covering the process from detection to action implementation. Signal detection is typically performed by safety scientists using qualitative and quantitative methods. Validated signals undergo thorough assessment, and confirmed signals may lead to regulatory actions such as label updates or market withdrawal. Traditional methods are challenged by growing data volumes, prompting the adoption of artificial intelligence techniques. Despite promising results, regulatory gaps highlight the need for harmonised frameworks to fully leverage artificial intelligence while maintaining ethical standards.
As the clinical trial industry evolves, generative artificial intelligence (GenAI) and machine learning are being rapidly adopted within clinical trial activities to support trial design, planning, execution, and regulatory submissions. Traditional authoring practice for clinical and regulatory documents involves unstructured content development, an approach that limits the opportunity to use GenAI efficiently. The industry is pivoting towards a more systematic approach, employing structured, reusable content that supports digital data flow and GenAI functionality. Incorporation of GenAI into the day-to-day work of medical writers remains an area of intense focus. Within Parexel medical writing services, the implementation of structured content authoring is fully adopted and being used on a wide variety of safety and regulatory documents. This is reflected in survey results from safety medical writers reporting their authoring experiences on the structured content platform. Although GenAI augmentation remains in its infancy, in this article, we describe our efforts towards implementation, including the approach to prompt development and advantages for augmenting medical writing workflows.
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.
With ever increasing complexity in clinical studies and development programmes, clear and informative reporting of safety data is now more important than ever. The medical writer has a key role in guiding the team on the best approach for communicating the key safety findings. This article reviews strategies the writer can use when developing clinical study report safety sections and the Common Technical Document Module 2.7.4 Summary of Clinical Safety.
Postmarketing safety writing plays a vital role in the ongoing evaluation of drug products after marketing authorisation. This article explores the objectives, regulatory framework, key deliverables, and best practices associated with postmarketing safety docu mentation. From adverse event narratives and Periodic Benefit-Risk Evaluation Reports to Risk Management Plans, postmarketing safety writing is fundamental to maintaining the benefit-risk balance of medicinal products. With growing demands for transparency and harmonised global regulations, medical writers must adapt to evolving expectations in pharmacovigilance reporting.
This article explores the critical role of language access in healthcare, emphasising its direct impact on the health outcomes of linguistic minority communities. Despite legal frame works, the implementation of effective language services remains inconsistent across global healthcare systems, risking patient safety and exacerbating health disparities. The authors argue that language should be viewed as a fundamental component of healthcare infra structure, not a peripheral concern, and high light the dangers of relying on AI-driven translation tools without expert linguist oversight. By advocating for Participatory Action Research, the authors call for a collaborative, human-centred approach to developing language access solutions that ensure equitable, safe, and culturally relevant care. Ultimately, they stress that healthcare systems must prioritise language justice, both to fulfil ethical obligations and to enhance institutional resilience, urging a co-design of language access tools and systems that includes language access practitioners, patients, and care teams.
Effective pharmacovigilance is essential to ensuring the long-term safety and efficacy of medications, particularly in the post-authorisation phase of pharmaceutical research. Comprehensive methods for evaluating drug safety not only support regulatory compliance but also strengthen the prescribing confidence of healthcare providers. As a critical component of regulatory science, pharmacovigilance requires active engagement from all stakeholders – regulatory bodies, healthcare professionals, and patients alike. Central to this process is the pharmacovigilance medical writer, who plays a pivotal role in leading the development of high-quality safety documents for regulatory submission. This role demands cross-functional coordination, expert knowledge of regulatory guidelines, and an ability to synthesise complex input from multiple disciplines. Ultimately, the goal is to produce clear, compliant, and globally acceptable documents that reflect the evolving safety profile of pharmaceutical products.
