One of the most experienced pharmacovigilance and pharmacoepidemiology experts in the world.
Specialist Pharmacovigilance Consultant Europe
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 Europe
Pharmacovigilance Consultant Europe
Saad Shakir is a leading expert in pharmacovigilance and pharmacoepidemiology in Europe.
Saad Shakir is a highly regarded Pharmacovigilance Consultant in Europe, with extensive senior-level experience in pharmacovigilance, pharmacoepidemiology, and risk management. His career includes leadership positions within the UK Regulatory Authority, GSK, and RPR, followed by his tenure as Director of the Drug Safety Research Unit in Southampton. In June 2025, he launched his independent consultancy, offering expert drug safety advisory services and Pharmacovigilance Training in the UK and Europe to organisations seeking regulatory excellence and compliance.
As a leading Pharmacovigilance Consultant in Europe, Saad has provided guidance on complex, high-profile drug safety issues, including product withdrawals, usage restrictions, deregulation initiatives, and critical safety programmes. He combines in-depth clinical expertise with advanced pharmacovigilance and epidemiological knowledge, underpinned by a comprehensive understanding of UK and EU regulatory frameworks. His experience includes overseeing PASS studies focused on risk management, risk minimisation, and a wide spectrum of real-world observational data research.
Saad delivers strategic advice on safety submissions and regulatory responses, collaborating with many of the world’s top twenty pharmaceutical companies, as well as medium-sized and emerging organisations. Beyond 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 spanning 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 across the UK and Europe. A sought-after speaker, he regularly presents keynote lectures at scientific conferences, championing best practices and regulatory excellence in pharmacovigilance.
Professor Saad Shakir
MB ChB, LRCP&S FRCP FISPE MRCGP
Global Drug Safety Consultancy & Pharmacovigilance Consultant Europe
Saad Shakir is a highly respected Pharmacovigilance Consultant in Europe and a recognised authority in pharmacovigilance and pharmacoepidemiology. He provides expert Pharmacovigilance Training across the UK and Europe for professionals and organisations seeking regulatory excellence and compliance. Saad has held senior leadership positions 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 established his independent consultancy, Adroit Vigilance, offering specialist pharmacovigilance advisory services, advanced training programmes, and strategic drug safety expertise to organisations across Europe.
Our Services
Drug safety services are essential for protecting patient wellbeing and maintaining trust in healthcare systems across Europe. A Pharmacovigilance Consultant in Europe supports this process through continuous monitoring and evaluation of adverse drug reactions, comprehensive risk assessments, and the implementation of effective risk minimisation strategies.
By systematically collecting and analysing safety data, potential risks associated with medicines can be identified early, enabling informed clinical and regulatory decision-making. Pharmacovigilance training across Europe equips professionals with the knowledge and skills needed to ensure safe medicine use, prevent misuse, and uphold responsible pharmacovigilance practices.
With a strong emphasis on patient safety, regulatory compliance, and therapeutic effectiveness, pharmacovigilance and drug safety services enhance patient outcomes while reinforcing confidence in pharmaceutical products throughout Europe.
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 in Europe, we engage in international collaborative projects aimed at advancing pharmacovigilance standards and promoting patient safety. These initiatives are designed to drive innovation within the field, reinforce regulatory best practices, and deliver enhanced patient outcomes across Europe and beyond.
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 in Europe, for consultancy support or speaking engagements – including Pharmacovigilance Training across Europe – please use the same form. For urgent enquiries, Saad may be contacted directly using the details below; however, due to international travel commitments, response times may vary.
To help us provide the most effective support, please include 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.