Specialist Pharmacoepidemiology Consultant 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
Pharmacoepidemiology Consultant USA
Pharmacoepidemiology Consultant USA
Pharmacoepidemiology Consultant USA
Professor Saad Shakir is a highly respected Pharmacoepidemiology Consultant USA, internationally recognised for his expertise in pharmacovigilance, pharmacoepidemiology, and drug safety governance. He provides specialist consultancy and advanced training services to pharmaceutical companies, regulatory authorities, and global healthcare organisations across the United States and internationally. 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. In June 2025, he established his independent consultancy, delivering expert drug safety advisory services and pharmacovigilance training throughout the USA and worldwide.
As a leading Pharmacoepidemiology Consultant USA, Professor Shakir advises on complex and high-risk drug safety challenges, including product withdrawals, risk management and mitigation strategies, regulatory submissions, and large-scale pharmacovigilance programmes. He combines strong clinical insight with advanced epidemiological methodologies to support PASS studies, risk minimisation plans, real-world evidence generation, and post-authorisation safety strategies, underpinned by in-depth knowledge of US, UK, and EU regulatory frameworks.
He 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 operating within the US market. His experience also includes extensive collaboration with regulatory bodies and international institutions, where he has served as Chair or member of Safety Advisory Boards and Data Safety Monitoring Committees.
A widely published and authoritative figure, Professor Shakir has authored numerous book chapters, peer-reviewed journal articles, and conference abstracts in pharmacovigilance, pharmacoepidemiology, and risk management. He also serves on editorial boards for leading journals, including Drug Safety and Pharmacoepidemiology and Drug Safety.
Committed to advancing global standards in drug safety, Professor Shakir delivers pharmacovigilance and pharmacoepidemiology training across the USA, the UK, and internationally. He is a frequent keynote speaker at scientific and regulatory conferences, promoting best practice, regulatory compliance, and excellence in pharmacovigilance and pharmacoepidemiological research.
Professor Saad Shakir
MB ChB, LRCP&S FRCP FISPE MRCGP
Global Drug Safety Consultancy & Pharmacoepidemiology Consultant UK
Pharmacoepidemiology Consultant USA
Saad Shakir is a highly respected Pharmacoepidemiology Consultant USA, internationally recognised for his expertise in pharmacovigilance, pharmacoepidemiology, and drug safety across the United States, Europe, and global markets. He provides specialist pharmacovigilance consultancy and advanced professional training, supporting organisations and regulatory stakeholders in achieving regulatory compliance, operational excellence, and best practice in drug safety.
As a leading Pharmacoepidemiology Consultant USA, Saad has held senior leadership roles in pharmacovigilance, pharmacoepidemiology, and risk management within the UK Regulatory Authority, GSK, and RPR, before serving as Director of the Drug Safety Research Unit in Southampton. His career reflects extensive experience across regulatory, commercial, and academic environments, with a strong focus on US and international regulatory frameworks.
In June 2025, he established his independent consultancy, Adroit Vigilance, delivering expert pharmacovigilance advisory services, advanced training programmes, and strategic drug safety support. In his role as a Pharmacoepidemiology Consultant USA, he works with organisations to strengthen pharmacovigilance systems, enhance regulatory compliance, and implement robust risk management strategies aligned with US, UK, EU, and global regulatory requirements.
Our Services
Drug safety services are fundamental to protecting patient wellbeing and maintaining confidence in healthcare systems. A Pharmacoepidemiology Consultant USA plays a critical role in overseeing the monitoring and evaluation of adverse drug reactions, conducting rigorous risk assessments, and implementing effective risk minimisation strategies in line with US, UK, EU, and international regulatory requirements.
Through the structured collection, analysis, and interpretation of safety data, a Pharmacoepidemiology Consultant USA supports the early identification of medicine-related risks, enabling evidence-based clinical decision-making and timely regulatory action. High-quality pharmacovigilance training delivered across the USA, Europe, and internationally equips healthcare and life sciences professionals with the practical expertise required to ensure the safe and appropriate use of medicines, reduce the risk of misuse, and uphold best practice in pharmacovigilance.
By placing patient safety, regulatory compliance, and therapeutic effectiveness at the centre of drug safety strategy, the expertise of a Pharmacoepidemiology Consultant USA contributes to improved patient outcomes and helps reinforce 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 Pharmacoepidemiology Consultant USA, we actively engage in international collaborative projects focused on advancing pharmacovigilance standards and strengthening patient safety. These initiatives support innovation in drug safety and pharmacoepidemiology, promote regulatory best practice, and contribute to improved patient outcomes across the USA, 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 USA, for consultancy support or speaking engagements, including pharmacovigilance training delivered across the USA, Europe, or internationally, please complete the enquiry form. For urgent matters, Professor Shakir may be contacted directly using the details below, although response times may vary due to international professional commitments.
To ensure the most effective support, please provide a clear outline of your requirements and objectives. Alternatively, you may contact us by email or telephone to arrange a consultation or a bespoke training programme with an experienced Pharmacoepidemiology Consultant USA.