Professor Saad Shakir
MB, ChB LRCP&S FRCP FISPE FISOP
Pharmacovigilance & Pharmacoepidemiology
One of the most experienced pharmacovigilance and pharmacoepidemiology experts in the world.
Professor Saad Shakir
Consultant - Pharmacovigilance & Pharmacoepidemiology
One of the most experienced pharmacovigilance and pharmacoepidemiology experts in the world.
Global Drug Safety Consultancy
Professor Saad Shakir
MB, ChB LRCP&S FRCP FISPE FISOP
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 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.
He 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.
He has 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.
Global Drug Safety Consultancy
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, Adroitvigilance in June 2025.
Our Services
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.
Our Services
Drug safety services play a crucial role in ensuring the well-being of patients and the integrity of healthcare systems. These services encompass a comprehensive range of activities, including the monitoring and evaluation of adverse drug reactions, risk assessment, and the implementation of safety measures. Professionals in the field collect and analyse data to identify potential safety issues associated with medications, thereby contributing to informed decision-making for healthcare providers and patients alike. Ongoing education and training about safe medication practices are integral to these services, as they aim to prevent misuse and promote responsible drug utilisation. By prioritising safety and efficacy, drug safety services ultimately enhance patient care and foster trust in pharmaceutical products.
Our Courses & Meetings
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.
Our Courses
Our courses provide essential knowledge and skills to ensure the safe handling and administration of pharmaceuticals. Participants engage in comprehensive modules covering topics such as drug classifications, potential side effects, and best practices for storage and disposal. Through a combination of lectures, case studies, and practical exercises, attendees learn to identify and mitigate risks associated with drug use in various settings. Emphasis is placed on regulatory compliance and ethical considerations, preparing individuals to uphold safety standards in their professional environments. These courses are crucial for healthcare professionals, pharmacists, and anyone involved in the management of medications, ensuring patient safety and effective care.
“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