Specialist Pharmacovigilance Advice 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 Advice Europe
Pharmacovigilance Advice Europe
Pharmacovigilance Advice Europe
Professor Saad Shakir is a recognised authority in pharmacoepidemiology and drug safety, with extensive international expertise in pharmacovigilance, regulatory governance, and risk management. Through Pharmacovigilance Training UK, he delivers specialist programmes and expert Pharmacovigilance Advice Europe, providing tailored training and consultancy for pharmaceutical companies, regulators, and healthcare organisations across Europe, the UK, and internationally.
His distinguished career includes senior leadership roles within the UK regulatory authority, GSK, and RPR, prior to his appointment as Director of the Drug Safety Research Unit in Southampton. In June 2025, Professor Shakir established an independent consultancy, offering expert Pharmacovigilance Advice Europe alongside advanced training programmes and bespoke solutions aligned with EU and global regulatory frameworks.
Through Pharmacovigilance Training UK, he addresses complex drug safety challenges, including risk management planning, regulatory submissions, product withdrawals, and the design and implementation of large-scale pharmacovigilance systems. His teaching integrates clinical insight with advanced epidemiological methods, supporting post-authorisation safety studies, real-world evidence generation, and robust risk minimisation strategies in line with EU, UK, and international regulatory requirements.
Professor Shakir also provides strategic oversight for safety submissions and regulatory responses, working closely with multinational pharmaceutical organisations, as well as mid-sized and emerging life sciences companies across Europe and beyond. He has extensive experience engaging with European regulatory authorities and global institutions and regularly 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 on pharmacovigilance, pharmacoepidemiology, and drug safety risk management. He serves on the editorial boards of leading journals, including Drug Safety and Pharmacoepidemiology and Drug Safety.
Committed to advancing medicine safety standards across the region, Professor Shakir continues to deliver high-level programmes and international training, sharing best practice and providing expert Pharmacovigilance Advice Europe at scientific and regulatory conferences worldwide.
Professor Saad Shakir
MB ChB, LRCP&S FRCP FISPE MRCGP
Global Drug Safety Consultancy & Pharmacovigilance Advice Europe
Pharmacovigilance Advice Europe
Saad Shakir is a highly respected authority in pharmacoepidemiology and drug safety, internationally recognised for his expertise in pharmacovigilance, regulatory drug safety, and pharmacoepidemiology across Europe, the UK, and global markets. Through Pharmacovigilance Training UK, he provides specialist consultancy and delivers expert Pharmacovigilance Advice Europe, alongside leading pharmacovigilance training programmes across the region. His services support pharmaceutical companies, life sciences organisations, and regulatory stakeholders in achieving best practice, regulatory compliance, and operational excellence in drug safety.
His distinguished career includes senior leadership roles within the UK regulatory authority, GSK, and RPR, followed by his appointment as Director of the Drug Safety Research Unit in Southampton. This extensive experience spans regulatory, commercial, and academic environments and is underpinned by in-depth knowledge of UK, EU, and international regulatory frameworks, enabling him to deliver authoritative Pharmacovigilance Advice Europe to organisations operating across European and global markets.
In June 2025, Saad established his independent consultancy, Adroit Vigilance, providing expert Pharmacovigilance Advice Europe, advanced professional training, and strategic drug safety support. Through Pharmacovigilance Training UK, he delivers comprehensive pharmacovigilance programmes that help organisations strengthen their systems, enhance regulatory compliance, and implement robust risk management strategies in line with EU, UK, and international requirements.
Our Services
Ensuring medicine safety is essential for protecting patient wellbeing and maintaining confidence in healthcare systems. Pharmacovigilance Training UK provides specialist Pharmacovigilance Advice Europe, alongside comprehensive pharmacovigilance courses across the continent. These programmes equip organisations with the knowledge and practical skills to monitor adverse drug reactions, conduct thorough risk assessments, and implement effective risk minimisation strategies in line with UK, EU, and international regulatory standards.
Through the structured collection, analysis, and interpretation of safety data, participants can identify potential medicine-related risks at an early stage. This approach supports evidence-based clinical decision-making and ensures timely regulatory action where necessary. Healthcare and life sciences professionals gain practical expertise to promote the safe and appropriate use of medicines, prevent misuse, and uphold the highest standards of pharmacovigilance practice.
With a strong focus on patient safety, regulatory compliance, and therapeutic effectiveness, the pharmacovigilance programme, supported by expert Pharmacovigilance Advice Europe, helps improve patient outcomes while reinforcing long-term trust 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 engage in international collaborations to advance pharmacovigilance standards and safeguard patient wellbeing. Through Pharmacovigilance Training UK, we provide expert Pharmacovigilance Advice Europe, alongside a comprehensive Pharmacovigilance Course Europe. Our services support innovation in drug safety, reinforce regulatory best practice, and promote consistent compliance across UK, European, and global regulatory frameworks.
The Pharmacovigilance Course Europe equips organisations with the tools to develop robust pharmacovigilance systems, enhance risk management procedures, and facilitate evidence-based regulatory decision-making. By sharing practical insights and international expertise, the programme provides healthcare and life sciences professionals with the skills required to improve patient outcomes and maintain the highest standards of drug safety across Europe, the UK, 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 consultant in pharmacoepidemiology, for expert Pharmacovigilance Advice Europe, speaking engagements, or a Pharmacovigilance Course Europe, please complete the enquiry form provided. For urgent matters, Professor Shakir can also be contacted directly using the details listed, although response times may vary due to international professional commitments.
To ensure the most effective and tailored support, we recommend providing clear and detailed information about your objectives and requirements. Alternatively, you may contact us by email or telephone to arrange a consultation or a bespoke Pharmacovigilance Course Europe, delivered by an experienced specialist in pharmacoepidemiology and drug safety.