About.

Saad Shakir is a leading expert in pharmacovigilance and pharmacoepidemiology in Europe. 

He has worked in pharmacovigilance, pharmacoepidemiology and risk management at the UK Regulatory Authority, GSK, RPR then became  Director of the Drug Safety Research Unit in Southampton. Saad has launched his independent consultancy in June 2025. 

He has worked and advised on major drug safety issues including product withdrawals, restrictions of use, deregulation and other important safety projects. He combines his clinical, pharmacovigilance, epidemiological expertise with understanding of pharmacovigilance regulations and requirements in the EU and the UK. Saad has led conducting  PASS studies for risk management, risk minimisation and a range of other observational real world data studies . 

Saad advises on safety submissions and responses to regulatory authorities. He has worked with or advised most of the top twenty pharmaceutical companies and many medium and small companies. 

In addition to pharmaceutical companies, Saad advised regulatory authorities and other organisations around the world. He served as a Chairman or member of Safety Advisory Boards and Data Safety Management Committees.  He is an author of book chapters and hundreds  publications and conference abstracts  on pharmacovigilance, pharmacoepidemiology and risk management. Saad is a member of the editorial boards for the journals Drug Safety and Pharmacoepidemiology and Drug Safety.

Saad Shakir is heavily involved with training  and education worldwide. He has been invited to speak in scientific conferences, including keynote lectures around the world. He leads  international projects  to advance  pharmacovigilance.