Pharmacovigilance Consultant, Physician, and Pharmacoepidemiologist

Saad Shakir is widely recognised as one of Europe’s leading experts in pharmacovigilance and pharmacoepidemiology.

Saad Skair 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 Shakir 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 Shakir has 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).

Saad Shakir was among the first members of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) and currently serves as Chairperson of the Global Advisory Committee for Risk Management and Communications for the Saudi FDA.

As an active leader in the field, he has led international initiatives to advance pharmacovigilance. He is the Founder and Chairperson of the International Working Group on Innovations in Pharmacovigilance (IWG).

Combining medical and scientific expertise with a deep understanding of pharmacovigilance regulations and healthcare systems, Saad Shakir has authored more than 200 peer‑reviewed papers and hundreds of abstracts and conference presentations. He is frequently invited to deliver lectures, including keynote addresses, at international scientific meetings and by regulatory authorities, pharmaceutical companies, and universities.

Saad Shakir taught and provided training at universities around the world, including Oxford, London, Cardiff, Hertfordshire, King Saud, Dundee, and others.

Saad Shakir provides his consultancy and works alone or with associates and partners who are top international pharmacovigilance experts.

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