Specialist Pharmacoepidemiology Consultant UK
One of the most experienced pharmacovigilance and pharmacoepidemiology experts in the world.
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
Pharmacoepidemiology Consultant UK
Pharmacoepidemiology Consultant UK
Pharmacoepidemiology Consultant UK: Professor Saad Shakir is a leading authority in pharmacovigilance and pharmacoepidemiology, offering expert consultancy and training services to pharmaceutical companies, regulatory authorities, and global institutions. With a distinguished career spanning senior leadership roles at the UK Regulatory Authority, GSK, and RPR, followed by his tenure as Director of the Drug Safety Research Unit in Southampton, Professor Shakir launched his independent consultancy in June 2025, providing specialist drug safety consultancy and Pharmacovigilance Training UK.
As an experienced Pharmacoepidemiology Consultant UK, he advises on complex drug safety challenges, including product withdrawals, risk management strategies, regulatory submissions, and high-profile safety programmes. Combining clinical insight with advanced epidemiological expertise, he delivers comprehensive support for PASS studies, risk minimisation plans, and real-world evidence generation, underpinned by in-depth knowledge of UK, EU, and US regulatory frameworks.
Professor Shakir provides strategic guidance on safety submissions and regulatory responses, collaborating with top global pharmaceutical companies as well as mid-sized and emerging life sciences organisations. He has also served regulatory authorities and international institutions as Chair or member of Safety Advisory Boards and Data Safety Monitoring Committees.
A prolific author and recognised authority, he has contributed to numerous book chapters, peer-reviewed journals, and conference abstracts in pharmacovigilance, pharmacoepidemiology, and risk management, and serves on editorial boards including Drug Safety and Pharmacoepidemiology and Drug Safety.
Committed to advancing global education and professional development, Professor Shakir delivers pharmacovigilance training across the UK, USA, and internationally, and is regularly invited to present keynotes at scientific conferences, promoting best practice, regulatory compliance, and excellence in drug safety.
Professor Saad Shakir
MB ChB, LRCP&S FRCP FISPE MRCGP
Global Drug Safety Consultancy & Pharmacoepidemiology Consultant UK
Pharmacoepidemiology Consultant UK: Saad Shakir is a highly respected expert in pharmacovigilance and pharmacoepidemiology, recognised internationally across Europe and beyond. He delivers specialist Pharmacovigilance Training UK, as well as training and consultancy globally, supporting professionals and organisations in achieving regulatory compliance, best practice, and excellence in drug safety.
Saad has held senior leadership roles in pharmacovigilance, pharmacoepidemiology, and risk management at the UK Regulatory Authority, GSK, and RPR, before serving as Director of the Drug Safety Research Unit in Southampton.
In June 2025, he launched his independent consultancy, Adroit Vigilance, providing expert pharmacovigilance consultancy, advanced training programmes, and strategic drug safety guidance. As an experienced Pharmacoepidemiology Consultant UK, he helps organisations strengthen pharmacovigilance systems, enhance compliance standards, and implement robust risk management strategies within UK, US, and international regulatory frameworks.
Our Services
Drug safety services are essential for protecting patient wellbeing and maintaining trust in healthcare systems. A Pharmacoepidemiology Consultant UK plays a crucial role by overseeing the monitoring and evaluation of adverse drug reactions, conducting thorough risk assessments, and implementing effective risk minimisation strategies in line with UK, EU, and international regulatory requirements.
Through systematic collection, analysis, and interpretation of safety data, a Pharmacoepidemiology Consultant UK helps identify potential medicine-related risks early, supporting informed clinical decision-making and proactive regulatory measures. High-quality pharmacovigilance training in the UK, as well as internationally, equips professionals with the knowledge and practical expertise required to ensure the safe use of medicines, prevent misuse, and uphold best practice in pharmacovigilance.
By prioritising patient safety, regulatory compliance, and therapeutic effectiveness, the services of a Pharmacoepidemiology Consultant UK contribute to improved patient outcomes and reinforce long-term confidence in pharmaceutical products and healthcare providers.
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 Pharmacoepidemiology Consultant UK, we actively participate in international collaborative projects designed to advance pharmacovigilance standards and strengthen patient safety. These initiatives drive innovation within the field, promote regulatory best practice, and support improved patient outcomes across the UK, Europe, and globally.
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 Pharmacoepidemiology Consultant UK, for consultancy support or speaking engagements, including pharmacovigilance training in the UK, USA, or internationally, please complete the enquiry form. For urgent matters, Professor Shakir can be contacted directly using the details below; however, response times may vary due to international commitments.
To help us assist you efficiently, please provide a clear overview of your requirements and objectives. Alternatively, you are welcome to contact us via email or telephone to arrange a consultation or bespoke training session with a Pharmacoepidemiology Consultant UK.