Specialist Pharmacovigilance Training 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 Training USA
Pharmacovigilance Training USA
Pharmacovigilance Training USA
Professor Saad Shakir is a highly regarded authority in pharmacoepidemiology and drug safety, internationally recognised for his expertise in pharmacovigilance, regulatory governance, and risk management. He delivers specialised pharmacovigilance training in the USA, supporting pharmaceutical companies, regulatory authorities, and healthcare organisations operating across North American and global markets.
His distinguished career encompasses 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 tailored programmes for organisations in the USA.
Through pharmacovigilance training in the USA, Professor Shakir advises on complex and high-risk drug safety challenges such as product withdrawals, risk management and mitigation strategies, regulatory submissions, and large-scale pharmacovigilance systems. He integrates deep clinical insight with advanced epidemiological methodologies to support post-authorisation safety studies (PASS), real-world evidence generation, and robust risk minimisation plans. His work is informed by extensive knowledge of EU, UK, and US 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 operating in the USA and internationally. He has extensive experience working 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 covering 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 in the USA, across Europe, and internationally. He is a regular keynote speaker at scientific and regulatory conferences, promoting 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 USA
Saad Shakir is a highly respected specialist in pharmacoepidemiology and drug safety, internationally recognised for his expertise in pharmacovigilance, regulatory drug safety, and pharmacoepidemiology across the UK, the United States, Europe, and global markets. He provides specialist consultancy services and pharmacovigilance training in the USA, 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 in the USA.
In June 2025, Saad established his independent consultancy, Adroit Vigilance, delivering expert pharmacovigilance advisory services, advanced professional training programmes, and strategic drug safety support. Through pharmacovigilance training in the USA, he collaborates with organisations to strengthen pharmacovigilance systems, enhance regulatory compliance, and implement robust risk management strategies aligned with US, EU, UK, and global regulatory requirements.
Our Services
Drug safety services are essential for protecting patient wellbeing and maintaining confidence in healthcare systems. Pharmacovigilance training in the USA supports organisations in developing the expertise required to monitor and assess adverse drug reactions, conduct thorough risk evaluations, and implement effective risk minimisation strategies in line with US, EU, UK, and international regulatory standards.
Through systematic collection, analysis, and interpretation of safety data, pharmacovigilance training in the USA enables the early identification of medicine-related risks, supporting evidence-based clinical decisions and timely regulatory interventions. High-quality training equips healthcare and life sciences professionals with the practical knowledge needed to ensure the safe and appropriate use of medicines, reduce misuse, and maintain best-practice standards in pharmacovigilance.
By prioritising patient safety, regulatory compliance, and therapeutic effectiveness, pharmacovigilance training in the USA 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 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 leading authority in pharmacoepidemiology, we are actively engaged in international collaborative programmes aimed at advancing pharmacovigilance standards and enhancing patient safety. Through pharmacovigilance training in the USA, these initiatives foster innovation in drug safety and pharmacoepidemiology, promote regulatory best practice, and support consistent compliance across complex regulatory frameworks.
Our work in pharmacovigilance training in the USA helps organisations develop 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 improve patient outcomes and maintain high standards of drug safety across the USA, Europe, 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 in the USA, 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 USA programme delivered by an experienced pharmacoepidemiology specialist.