Rosalind (Ros) Coulson is a pharmaceutical expert who became a world leader in drug development, information sciences and pharmacovigilance – the science relating to the detection, assessment, monitoring, and prevention of the adverse effects of pharmaceutical products. In recognition of her services to the profession of pharmacy in the UK, Ros was made a Fellow of the Royal Pharmaceutical Society in 1992.

Rosalind Coulson enrolled into 5th Grade at MLC School in 1949 and completed her Leaving Certificate in 1955. During her time at MLC School she was a member of the ‘A’ Hockey and Tildesley Tennis teams and was on the Sports Committee. After leaving MLC School, Ros studied Pharmacology at the University of Sydney and became a registered pharmacist in 1959. Ros moved to the United Kingdom and competed a Master of Science in Biopharmaceutics in 1982 at King’s College, University of London.

During her 25-year tenure at the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, Ros held a number of roles. Initially she was the principal pharmaceutical officer and group manager, later moving to the Post-Licensing Division where she had oversight on the monitoring of the safety of all medicinal products in the UK.

In this role, Ros developed and implemented Adverse Drug Reaction Online Tracking (ADROIT) – the system used to monitor and research safety data of medicines and medical devices in the UK. Ros’ innovative ADROIT system won her a Smithsonian Institute (USA) award for its contribution to medical science. During this time, Ros also took on a special project to revitalise the UK General Practitioner’s Research Database. This remains one of the most important sources for pharmaco-epidemiological research in the UK today. Ros recently contacted us to say that the system is playing a pivotal role in the tracking of adverse reactions to COVID vaccinations in the UK: ‘These data are being recorded in the UK on the system we developed in the early 1990s and are being made available worldwide. Not in my wildest dreams would I have thought that it would become so important in the 21st century.’

After becoming a member of the International Conference on Harmonisation (ICH), Ros was successful in standardising the international medical terminology used by regulatory authorities and the biopharmaceutical industry worldwide by taking the medical dictionary she developed for her UK ADROIT system and developing MedDRA. MedDRA terminology is now used through the entire pharmaceutical regulatory process, from pre- to post-marketing, and data entry, retrieval, evaluation, and presentation.

Further, through her involvement in the European Union (EU) and the ICH she was instrumental in the development of the international standard for the electronic transmission of individual case safety reports related to medicinal products.

Upon retirement from the MHRA, Ros Coulson served as an independent consultant on the safety of medicines to European regulators, the pharmaceutical industry, and medical service providers.