One of the most experienced pharmacovigilance and pharmacoepidemiology experts in the world.
Specialist Pharmacovigilance Consultant UK
Professor Saad Shakir
Global Expert in Pharmacovigilance & Pharmacoepidemiology
★★★★★
“Collaborating with Professor Saad Shakir at Adroit Vigilance 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
Pharmacovigilance Consultant UK
Pharmacovigilance Consultant UK
Saad Shakir is a leading expert in pharmacovigilance and pharmacoepidemiology in Europe.
Saad Shakir is a highly respected Pharmacovigilance Consultant UK, with extensive senior-level experience across pharmacovigilance, pharmacoepidemiology, and risk management. His career includes leadership roles within the UK Regulatory Authority, GSK, and RPR, prior to serving as Director of the Drug Safety Research Unit in Southampton. In June 2025, he launched his independent consultancy, providing expert drug safety consultancy services and Pharmacovigilance Training UK to organisations seeking regulatory excellence and compliance.
As a leading Pharmacovigilance Consultant UK, Saad has advised on complex and high-profile drug safety challenges, including product withdrawals, usage restrictions, deregulation initiatives, and critical safety programmes. He combines deep clinical expertise with advanced pharmacovigilance and epidemiological knowledge, alongside a comprehensive understanding of UK and EU regulatory frameworks. His experience includes leading PASS studies focused on risk management, risk minimisation, and a wide range of real-world observational data studies.
Saad delivers strategic guidance on safety submissions and regulatory responses, working with many of the world’s top twenty pharmaceutical companies, as well as medium-sized and emerging organisations. In addition to industry leadership, he has advised regulatory authorities and international institutions, serving as Chair or member of Safety Advisory Boards and Data Safety Monitoring Committees.
A prolific author and recognised authority, Saad has contributed to book chapters and published hundreds of peer-reviewed journal articles and conference abstracts across pharmacovigilance, pharmacoepidemiology, and risk management. He also serves on the editorial boards of leading journals, including Drug Safety and Pharmacoepidemiology and Drug Safety.
Committed to advancing global education and professional development, Saad leads international initiatives and delivers Pharmacovigilance Training UK and worldwide. As a sought-after speaker, he regularly presents keynote lectures at scientific conferences, promoting best practice and regulatory excellence in pharmacovigilance.
Professor Saad Shakir
MB ChB, LRCP&S FRCP FISPE MRCGP
Global Drug Safety Consultancy & Pharmacovigilance Consultant UK
Saad Shakir is a highly respected Pharmacovigilance Consultant UK and a recognised leader in pharmacovigilance and pharmacoepidemiology across Europe. He delivers expert Pharmacovigilance Training UK for professionals and organisations striving for regulatory excellence and compliance. Saad has held senior leadership roles in pharmacovigilance, pharmacoepidemiology, and risk management within the UK Regulatory Authority, GSK, and RPR, before serving as Director of the Drug Safety Research Unit in Southampton.
In June 2025, he founded his independent consultancy, Adroit Vigilance, providing specialist pharmacovigilance consultancy, advanced training, and strategic drug safety expertise.
Our Services
Drug safety services play a critical role in safeguarding patient wellbeing and maintaining trust in healthcare systems worldwide. A Pharmacovigilance Consultant UK supports this process through the ongoing monitoring and evaluation of adverse drug reactions, robust risk assessment, and the implementation of effective risk minimisation measures.
By systematically collecting and analysing safety data, potential risks associated with medicines can be identified at an early stage, enabling informed clinical and regulatory decision-making. Pharmacovigilance Training UK is essential in equipping professionals with the expertise required to promote safe medicine use, prevent misuse, and ensure responsible pharmacovigilance practices.
With a strong focus on safety, regulatory compliance, and therapeutic efficacy, pharmacovigilance and drug safety services improve patient outcomes and reinforce confidence in pharmaceutical products.
Consultancy & Advice
We provide expert consultancy and advice in the fields of pharmacovigilance and pharmacoepidemiology. Our services include:
Risk Management: We handle risk management and risk minimization, including monitoring its effectiveness.
Safety Studies: We conduct Real World Studies and PASS (Post-Authorisation Safety Studies).
Benefit/Risk Evaluation: We perform thorough benefit/risk evaluations.
Regulatory Submissions: We assist with pharmacovigilance submissions and responses to regulatory authorities.
ADR Assessment: We provide assessment of single and clusters of Adverse Drug Reaction (ADR) reports.
Specialised Boards: Saad is experienced in working with Data Safety Management Boards and Advisory Committees.
Medicolegal Work: We also undertake medicolegal work.
Training & Education
Our courses deliver the essential knowledge and practical skills required for the safe handling, management, and administration of medicines. Through Pharmacovigilance Training UK, participants complete structured modules covering drug classifications, adverse effects, and best practice guidance for storage, handling, and disposal. Learning is supported by expert-led sessions, real-world case studies, and practical exercises, enabling attendees to identify, assess, and mitigate medication-related risks across a range of settings. Strong emphasis is placed on regulatory compliance, ethical responsibility, and patient safety, equipping healthcare professionals, pharmacists, and medicine management teams with the confidence to maintain the highest standards of care.
We are committed to training and education on a wide range of topics in pharmacovigilance and pharmacoepidemiology. Our training is delivered through various formats:
Delivery Methods: Training can be delivered online, hybrid, or face-to-face.
Training Options: We offer in-house training, specific training courses, and conferences.
Collaborative Projects
As a Pharmacovigilance Consultant UK, we actively participate in international collaborative projects focused on advancing pharmacovigilance standards and enhancing patient safety. These initiatives are designed to support innovation within the field, strengthen regulatory best practice, and deliver improved patient outcomes on a global scale.
For general enquiries about AdroitVigilance and our services or courses, please fill out the form provided.
If you wish to engage Professor Saad Shakir, a leading Pharmacovigilance Consultant UK, for consultancy support or speaking engagements - including Pharmacovigilance Training UK - please use the same form. For urgent matters, Saad may be contacted directly using the details below; however, due to international travel commitments, response times may vary.
To enable us to support you effectively, please provide a clear outline of your requirements and intended outcomes. Alternatively, you are welcome to contact us by email or telephone to arrange a consultation or training session..