Professor Saad Shakir
MB, ChB LRCP&S FRCP FISPE FISOP
A world leading expert in Pharmacovigilance & Pharmacoepidemiology.
Pharmacovigilance Consultant, Physician, and Pharmacoepidemiologist
Saad Shakir is widely recognised as one of Europe’s leading experts in pharmacovigilance and pharmacoepidemiology.
He has led teams across major areas of pharmacovigilance, including risk management and benefit–risk evaluation. His experience spans regulatory submissions and responses, the design and conduct of real‑world pharmacoepidemiological studies, including PASS, the generation and assessment of real‑world evidence (RWE), and expert involvement in medicolegal cases, both individual cases and large group actions.
Saad advises on both strategic and operational matters. He is one of the very few global experts who has worked across every corner of pharmacovigilance during his distinct career: as a practising physician, in senior roles at the UK regulatory authority and at GSK, and as the head of an independent pharmacovigilance and pharmacoepidemiology unit.
Saad has also collaborated with and advised most of the world’s top ten pharmaceutical companies, numerous small and medium‑sized companies, and regulatory authorities internationally. He has served as chair and member of multiple Safety Advisory Committees and Data Safety Monitoring Boards (DSMBs).
Consultancy & Advice
Saad Shakir provides flexible, dynamic support tailored to each sponsor’s needs. His work ranges from high‑level strategic and operational advice to hands‑on delivery, either personally or in collaboration with his associates.
Having carefully considered how pharmacovigilance training should evolve to meet the needs of today’s pharmacovigilance professionals. This reflection has been shaped by discussions with colleagues and prospective delegates, as well as my own teaching experience.
Education & Training
“Collaborating with Professor Saad Shakir at ADROITVIGILANCE has significantly benefited our organisation. His pharmacovigilance and pharmacoepidemiology expertise deepens our drug safety understanding and fosters team adaptability. His guidance enhances patient outcomes and ensures proactive industry responses. We value his impactful commitment to excellence.”
– Dr. Edmund Burke