Specialist Pharmacovigilance Training Europe
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
Pharmacovigilance Training Europe
Pharmacovigilance Training Europe
Pharmacovigilance Training Europe
Professor Saad Shakir is a leading authority in pharmacoepidemiology and drug safety, internationally recognised for his expertise in pharmacovigilance, regulatory governance, and risk management. He delivers specialised Pharmacovigilance Training Europe, supporting pharmaceutical companies, regulatory authorities, and healthcare organisations operating across European and global markets.
His distinguished career includes senior roles 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 an independent consultancy, providing expert drug safety advisory services and advanced pharmacovigilance training worldwide, including bespoke programmes for organisations across Europe.
Through Pharmacovigilance Training Europe, Professor Shakir addresses complex drug safety challenges such as product withdrawals, risk management strategies, regulatory submissions, and large-scale pharmacovigilance systems. He combines clinical insight with advanced epidemiological methods to support post-authorisation safety studies (PASS), real-world evidence generation, and robust risk minimisation plans, drawing on extensive knowledge of EU, UK, and international regulatory frameworks.
Professor Shakir provides strategic oversight for safety submissions and regulatory responses, collaborating closely with multinational pharmaceutical companies as well as mid-sized and emerging life sciences organisations across Europe and internationally. He has extensive experience with regulatory bodies and international institutions, serving as Chair or member of Safety Advisory Boards and Data Safety Monitoring Committees.
A prolific author, he has published numerous peer-reviewed journal articles, book chapters, and conference abstracts on pharmacovigilance, pharmacoepidemiology, and drug safety risk management. He also serves on editorial boards for leading journals, including Drug Safety and Pharmacoepidemiology and Drug Safety.
Dedicated to advancing global standards in drug safety, Professor Shakir delivers Pharmacovigilance Training Europe and internationally, regularly speaking at scientific and regulatory conferences to promote best practice, regulatory compliance, and excellence in pharmacovigilance and pharmacoepidemiology.
Professor Saad Shakir
MB ChB, LRCP&S FRCP FISPE MRCGP
Global Drug Safety Consultancy & Pharmacoepidemiology Consultant UK
Pharmacovigilance Training Europe
Saad Shakir is a highly respected expert in pharmacoepidemiology and drug safety, internationally recognised for his knowledge of pharmacovigilance, regulatory drug safety, and pharmacoepidemiology across the UK, Europe, the United States, and global markets. He provides specialist consultancy and delivers Pharmacovigilance Training Europe, supporting pharmaceutical companies, life sciences organisations, and regulatory stakeholders in achieving operational excellence, regulatory compliance, and best practice in drug safety.
His distinguished career includes senior leadership roles within the UK Regulatory Authority, GSK, and RPR, followed by his tenure as Director of the Drug Safety Research Unit in Southampton. This experience spans regulatory, commercial, and academic environments, underpinned by in-depth knowledge of EU, UK, US, and international regulatory frameworks relevant to organisations operating across Europe.
In June 2025, Saad established his independent consultancy, Adroit Vigilance, providing expert pharmacovigilance advisory services, advanced professional training programmes, and strategic drug safety support. Through Pharmacovigilance Training Europe, he works with organisations to strengthen pharmacovigilance systems, enhance regulatory compliance, and implement robust risk management strategies aligned with EU, UK, and global regulatory requirements.
Our Services
Drug safety services are vital for protecting patient wellbeing and maintaining confidence in healthcare systems. Pharmacovigilance Training Europe helps organisations develop the expertise needed to monitor and assess adverse drug reactions, carry out thorough risk evaluations, and implement effective risk minimisation strategies in line with EU, UK, and international regulatory standards.
Through systematic collection, analysis, and interpretation of safety data, Pharmacovigilance Training Europe enables the early identification of medicine-related risks, supporting evidence-based clinical decisions and timely regulatory interventions. High-quality training provides healthcare and life sciences professionals with practical knowledge to ensure the safe and appropriate use of medicines, reduce misuse, and uphold best-practice standards in pharmacovigilance.
By prioritising patient safety, regulatory compliance, and therapeutic effectiveness, Pharmacovigilance Training Europe contributes to improved patient outcomes and reinforces long-term trust 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 provide essential knowledge and practical skills for the safe handling, management, and administration of medicines. Through Pharmacovigilance Training Europe, participants complete structured modules covering drug classifications, adverse effects, and best-practice guidance for storage, handling, and disposal. Learning is enhanced through expert-led sessions, real-world case studies, and practical exercises, enabling attendees to identify, assess, and mitigate medication-related risks across diverse settings. Strong emphasis is placed on regulatory compliance, ethical responsibility, and patient safety, equipping healthcare professionals, pharmacists, and medicines management teams with the confidence to uphold 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 leading authority in pharmacoepidemiology, we actively participate in international collaborative programmes aimed at advancing pharmacovigilance standards and improving patient safety. Through Pharmacovigilance Training Europe, these initiatives foster innovation in drug safety and pharmacoepidemiology, promote regulatory best practice, and support consistent compliance across complex European and global regulatory frameworks.
Our work in Pharmacovigilance Training Europe helps organisations build robust safety systems, strengthen risk management frameworks, and support evidence-based regulatory decision-making. By sharing global expertise and practical insights, we enable healthcare and life sciences organisations to enhance patient outcomes and maintain high standards of drug safety across Europe, the USA, and international healthcare markets.
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, for specialist consultancy, speaking engagements, or Pharmacovigilance Training Europe, please complete the enquiry form. For urgent matters, Professor Shakir can also be contacted directly using the details provided; however, response times may vary due to international professional commitments.
To ensure the most effective support, we recommend providing your objectives and requirements in as much detail as possible. Alternatively, you may contact us by email or telephone to arrange a consultation or a bespoke Pharmacovigilance Training Europe programme delivered by an experienced pharmacoepidemiology specialist.