Manjit Virdee

PV QA Manager

GSK

Manjit has twenty years of experience in Pharmacovigilance working both in industry and for a regulatory authority. He worked in the global safety groups at Roche and Amgen between 2001 – 2007 which gave him a good understanding of day to day case handling activities and how this impacts periodic reporting and signal detection. Manjit joined the MHRA as a Pharmacovigilance inspector in 2007 and conducted over one hundred inspections of a diverse range of companies. During his time at the MHRA he was involved in writing the Good Pharmacovigilance Practice guide and producing inspection metrics reports for the MHRA website. He also had the opportunity to interact with inspectors from many other EU agencies and presented on behalf of the MHRA at many symposia and conferences. In 2013 he joined GSKs PV audit group where he has been responsible for conducting audits of local operating companies, licensing partners and service providers (e.g. patient support programme (PSP) and market research (MR) vendors). He has also been heavily involved in managing regulatory authority inspections and audits from licensing partners.