Specialist Pharmacovigilance Course USA
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 Course USA
Pharmacovigilance Course USA
Pharmacovigilance Course USA
Professor Saad Shakir is a leading authority in pharmacoepidemiology and drug safety, with extensive international expertise in pharmacovigilance, regulatory governance, and risk management. He delivers a specialist Pharmacovigilance Course USA through Pharmacovigilance Training UK, providing tailored learning for pharmaceutical companies, regulators, and healthcare organisations across the US, Europe, the UK, and globally.
His distinguished career includes senior positions at the UK regulatory authority, GSK, and RPR, followed by his appointment as Director of the Drug Safety Research Unit in Southampton. In June 2025, he established an independent consultancy, offering expert drug safety advice alongside advanced Pharmacovigilance Course USA programmes and bespoke international training solutions.
Through Pharmacovigilance Training UK, Professor Shakir addresses complex drug safety challenges, including risk management planning, product withdrawals, regulatory submissions, and the development of large-scale pharmacovigilance systems. His teaching combines clinical expertise with advanced epidemiological methods, supporting post-authorisation safety studies, real-world evidence generation, and robust risk minimisation strategies, in line with US, EU, UK, and international regulatory standards.
He also provides strategic oversight for safety submissions and regulatory responses, working closely with multinational pharmaceutical companies, as well as mid-sized and emerging life sciences organisations across the US, UK, and internationally. Professor Shakir has extensive experience liaising with regulatory authorities and global institutions, serving on Safety Advisory Boards and Data Safety Monitoring Committees.
A prolific author, he has published widely in peer-reviewed journals, book chapters, and conference proceedings on pharmacovigilance, pharmacoepidemiology, and drug safety risk management. He serves on editorial boards for leading publications, including Drug Safety and Pharmacoepidemiology and Drug Safety.
Committed to advancing global medicine safety standards, Professor Shakir regularly delivers top-tier Pharmacovigilance Course USA programmes and international sessions, sharing his expertise 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 & Pharmacovigilance Course USA
Pharmacovigilance Course USA
Saad Shakir is a highly respected expert in pharmacoepidemiology and drug safety, internationally recognised for his expertise in pharmacovigilance, regulatory drug safety, and pharmacoepidemiology across the UK, Europe, the United States, and global markets. He provides specialist consultancy and delivers a leading Pharmacovigilance Course USA through Pharmacovigilance Training UK, supporting 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 at 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 sectors, underpinned by detailed knowledge of UK, EU, US, and international regulatory frameworks, enabling him to support organisations operating across the US, Europe, and worldwide.
In June 2025, Saad founded his independent consultancy, Adroit Vigilance, providing expert pharmacovigilance advisory services, advanced professional training, and strategic drug safety support. Through Pharmacovigilance Training UK, he delivers a comprehensive Pharmacovigilance Course USA, helping organisations strengthen pharmacovigilance systems, enhance regulatory compliance, and implement robust risk management strategies aligned with UK, EU, US, and international requirements.
Our Services
Ensuring drug safety is critical for protecting patient wellbeing and maintaining trust in healthcare systems. Pharmacovigilance Training UK delivers a specialist Pharmacovigilance Course USA, providing organisations with the knowledge and skills required to monitor adverse drug reactions, carry out comprehensive risk assessments, and implement effective risk minimisation strategies in line with US, UK, EU, and international regulatory standards.
Through systematic collection, analysis, and interpretation of safety data, the course equips participants to identify medicine-related risks early, enabling evidence-based clinical decisions and timely regulatory action. Healthcare and life sciences professionals gain practical expertise to ensure the safe and appropriate use of medicines, prevent misuse, and maintain high standards in pharmacovigilance.
By emphasising patient safety, regulatory compliance, and therapeutic effectiveness, the Pharmacovigilance Course USA supports improved patient outcomes and strengthens long-term confidence in healthcare providers 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 actively participate in international collaborations to advance pharmacovigilance standards and protect patient wellbeing. Through Pharmacovigilance Training UK, we deliver a comprehensive Pharmacovigilance Course USA that promotes innovation in drug safety, reinforces regulatory best practice, and ensures consistent compliance across US, UK, European, and global regulatory frameworks.
Our programme helps organisations establish robust safety systems, strengthen risk management processes, and support evidence-based regulatory decision-making. By sharing practical insights and international expertise, the Pharmacovigilance Course USA equips healthcare and life sciences professionals to enhance patient outcomes and maintain the highest standards of drug safety across the USA, UK, Europe, 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 pharmacoepidemiology consultant, for specialist advice, speaking engagements, or a Pharmacovigilance Course USA, please complete the enquiry form. For urgent matters, Professor Shakir can also be contacted directly using the details provided, though response times may vary due to international professional commitments.
To ensure the most effective support, we recommend providing comprehensive details of your objectives and requirements. Alternatively, you may contact us by email or telephone to arrange a consultation or a bespoke Pharmacovigilance Course USA delivered by an experienced pharmacoepidemiology specialist.