Graham is a very experienced member of Regulis’ Drug Safety team. He works with clients to deliver drug safety expertise, risk minimisation knowledge and pharmacovigilance compliance to their projects.
Value to clients
Graham knows how to run a pharmacovigilance system with drug safety experience spanning more than 20 years. He provides expertise at all levels in safety-related matters, including adverse event evaluation in development and post-marketing compounds, authorship of PADERs, PBRERS and DSURs, Risk Management Plans and medical support to all Regulatory submissions and associated documentation.
- Has worked in local, EU and global drug safety positions
- Experienced in regulatory authority pharmacovigilance inspections
- Highly proficient in signal detection and evaluation
- Has acted as QPPV
- ABPI Code of Practice trained.
Graham qualified in medicine from the Universities of St Andrews and Manchester. He joined Schering Healthcare Ltd in 1996 as Head of Drug Safety and has since held senior Pharmacovigilance positions in Johnson & Johnson (Janssen-Cilag), Biogen and Mitsubishi Tanabe Pharma Europe, where he was the EU QPPV for several years before joining Regulis.
Other things about Graham
- Spent 17 years with the Royal Navy as Medical Officer
- Has clinical experience in Hospital and Aviation Medicine, Pathology and General Practice
- Fellow of Faculty of Pharmaceutical Medicine.