Specialist Pharmacovigilance Consultant Lyon
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 Consultant Lyon
Pharmacovigilance Consultant Lyon
Pharmacovigilance Consultant Lyon
Professor Saad Shakir is a recognised expert in pharmacoepidemiology and drug safety, with extensive international experience in pharmacovigilance, regulatory compliance, and risk management. Through Pharmacovigilance Training UK, he provides specialist programmes and tailored support as a Pharmacovigilance Consultant in Lyon, offering strategic guidance to pharmaceutical companies, healthcare organisations, and regulatory authorities across France, the UK, and internationally.
His distinguished career includes senior roles within the UK regulatory system, positions at GlaxoSmithKline and other global life sciences organisations, and leadership as Director of the Drug Safety Research Unit in Southampton. In June 2025, he established his independent consultancy, delivering expert Pharmacovigilance Consultant in Lyon services alongside customised international training solutions.
Professor Shakir assists organisations in managing complex drug safety challenges, including risk management planning, regulatory submissions, product withdrawals, and the design and implementation of robust pharmacovigilance systems. His teaching integrates clinical expertise with advanced epidemiological methods, supporting post-authorisation safety studies, real-world evidence generation, and effective risk minimisation strategies in line with EU, UK, and global regulatory standards.
He also provides strategic oversight for safety submissions and regulatory responses, collaborating with multinational, mid-sized, and emerging life sciences companies. With extensive experience engaging regulatory authorities and international institutions, he frequently serves on Safety Advisory Boards and Data Safety Monitoring Committees.
A prolific academic, Professor Shakir has published widely in peer-reviewed journals, book chapters, and conference proceedings covering pharmacovigilance, pharmacoepidemiology, and drug safety risk management.
Committed to advancing global medicine safety standards, he continues to deliver high-level programmes and international training, sharing best practices while providing specialist Pharmacovigilance Consultant in Lyon services at scientific and regulatory events worldwide.
Professor Saad Shakir
MB ChB, LRCP&S FRCP FISPE MRCGP
Global Drug Safety Consultancy & Pharmacovigilance Consultant Lyon
Pharmacovigilance Consultant Lyon
Saad Shakir is a highly regarded expert in pharmacoepidemiology and drug safety, internationally recognised for his proficiency in pharmacovigilance, regulatory compliance, and medicine safety across France, the UK, and global markets. Through Pharmacovigilance Training UK, he offers specialist consultancy and serves as a Pharmacovigilance Consultant in Lyon, delivering advanced training programmes throughout Europe. His work supports pharmaceutical companies, life sciences organisations, and regulatory authorities in achieving best practice, compliance, and operational excellence in drug safety.
Professor Shakir’s distinguished career includes senior leadership positions within the UK regulatory system, roles at GlaxoSmithKline, and other international life sciences organisations, followed by his tenure as Director of the Drug Safety Research Unit in Southampton. With extensive experience across regulatory, commercial, and academic sectors, he has comprehensive knowledge of UK, EU, US, and global regulatory frameworks, enabling him to advise organisations across Europe and worldwide with confidence.
In June 2025, Professor Shakir established his independent consultancy, Adroit Vigilance, providing expert Pharmacovigilance Consultant in Lyon services alongside advanced professional training and strategic drug safety support. Through Pharmacovigilance Training UK, he delivers tailored programmes designed to strengthen internal systems, enhance regulatory compliance, and implement robust risk management strategies in line with UK, EU, US, and international standards.
Our Services
Ensuring the safety of medicines is vital for protecting patients and maintaining trust in healthcare systems. Pharmacovigilance Training UK provides expert guidance from a specialist Pharmacovigilance Consultant in Lyon, alongside comprehensive training programmes delivered across Europe. These sessions equip organisations with the skills to monitor adverse drug reactions, carry out structured risk assessments, and implement effective risk minimisation strategies in line with regulatory requirements across the UK, EU, US, and other international jurisdictions.
Through the systematic collection, analysis, and interpretation of safety data, participants can identify potential medicine-related risks at an early stage. This evidence-based approach supports informed clinical decisions and enables timely regulatory interventions. Healthcare and life sciences professionals gain practical expertise to ensure medicines are used safely and appropriately, reduce the risk of misuse, and maintain high standards of pharmacovigilance practice.
With a strong focus on patient safety, regulatory compliance, and therapeutic effectiveness, programmes led by a specialist Pharmacovigilance Consultant in Lyon help organisations enhance patient outcomes while reinforcing long-term confidence in healthcare providers, regulatory frameworks, and 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 provide essential knowledge and practical skills 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 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 recognised authority in pharmacoepidemiology, we operate internationally to advance pharmacovigilance standards and protect patient safety. Through Pharmacovigilance Training UK, we offer expert guidance from a specialist Pharmacovigilance Consultant in Lyon, alongside a comprehensive pharmacovigilance training programme delivered across Europe. Our services support innovation in drug safety, reinforce regulatory best practice, and ensure consistent compliance with frameworks across the UK, European Union, United States, and other global regulatory jurisdictions.
The European pharmacovigilance programme enables organisations to implement robust safety monitoring systems, strengthen risk management processes, and support evidence-based regulatory decision-making. By sharing practical insights and international expertise, the programme equips healthcare and life sciences professionals to enhance patient outcomes while maintaining the highest standards of drug safety across UK, European, US, and global 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 expert in pharmacoepidemiology, for professional consultancy, speaking engagements, or a pharmacovigilance training programme across Europe, please complete the enquiry form provided. For urgent requests, Professor Shakir can also be contacted directly, although response times may vary due to international commitments.
To ensure the most effective support, we recommend providing clear and detailed information about your objectives and specific requirements. Alternatively, you may contact us by email or telephone to arrange a consultation or a bespoke European pharmacovigilance course delivered by an experienced specialist in drug safety and a recognised Pharmacovigilance Consultant in Lyon.