Ian Nicholls

We work with our clients to challenge the conventional wisdom of how to design, conduct and manage full blown PV functionality for the pharmaceutical giants, with huge product portfolios and thousands of ICSRs, to late-stage clinical trial companies, with one or two products and a handful of cases, and anyone in between.Ian graduated from University College, London, with an honours degree in Biochemistry and spent the early years of his career in senior management positions in the food industry delivering results for real before moving into consultancy where he has worked almost exclusively within the pharmaceutical and medical device industries since 2003.Ian’s first introduction to pharmaceuticals was in manufacturing, helping a client to reduce their manufacturing costs by 38%. He then moved into Quality, Compliance and Training (probably because he argued with them so much) and from there into Pharmacovigilance. Ian was a Director with Foresight International (which is now part of IQVIA) implementing large scale Oracle Argus Safety Database Systems.In the pharmaceutical industry Ian has worked with Abbvie, Alexion, Amgen, Astellas, Astra-Zeneca, Banner, BMS, DPx, DSM, Gilead, GSK, Novartis, Patheon, Sanofi, Sanofi Pasteur, SPMSD, UCB, and Pfizer.In the medical device industry Ian has worked with Cochlear, Cook Medical, DePuy Synthes, Ethicon, Getinge, GSK Vaccines, Johnson & Johnson, Maquet, Medtronic, Novartis Vaccines and Sanofi Insulin.Ian is trained as a Lead Auditor and has worked with companies to prepare for inspections as well as having assisted companies under consent decree and in receipt of FDA 483 warning letters to prepare and implement remediation plans and author responses to the FDA.He is an internationally published, best-selling author and lecturer having written numerous newspaper and magazine articles, white papers and four books, three of which are about Quality Management Systems. Ian’s other book is a Supervisory Management Training Manual which has been translated into 9 languages and is on sale in 13 countries.Please feel free to contact Ian at [email protected] or connect with Ian here on LinkedIn.