One of the most experienced pharmacovigilance and pharmacoepidemiology experts in the world.
Specialist Pharmacovigilance Consultant USA
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 USA
Pharmacovigilance Consultant USA
Saad Shakir is a leading expert in pharmacovigilance and pharmacoepidemiology in Europe. Saad Shakir is a highly respected Pharmacovigilance Consultant in USA, delivering senior-level expertise across pharmacovigilance, pharmacoepidemiology, and risk management. 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 launched his independent consultancy, providing specialist drug safety consultancy services and Pharmacovigilance Training UK to organisations in the USA seeking regulatory excellence, compliance, and robust safety governance.
As an experienced Pharmacovigilance Consultant in USA, Saad has advised on complex and high-profile drug safety challenges, including product withdrawals, usage restrictions, deregulation initiatives, and critical safety programmes. He combines strong clinical insight with advanced pharmacovigilance and epidemiological expertise, supported by an in-depth understanding of UK, EU, and US regulatory frameworks. His experience includes leading PASS studies focused on risk management, risk minimisation strategies, and the generation of high-quality real-world observational data.
Saad provides strategic leadership on safety submissions and regulatory responses, working with many of the world’s top twenty pharmaceutical companies, as well as mid-sized and emerging life sciences organisations operating in the USA and internationally. Beyond industry, he has advised regulatory authorities and global institutions, serving as Chair or member of Safety Advisory Boards and Data Safety Monitoring Committees.
A prolific author and recognised authority in his field, Saad has contributed to book chapters and authored hundreds of peer-reviewed journal articles and conference abstracts spanning pharmacovigilance, pharmacoepidemiology, and risk management. He also serves on the editorial boards of leading journals, including Drug Safety and Pharmacoepidemiology and Drug Safety.
Committed to advancing global education and professional development, Saad leads international initiatives and delivers pharmacovigilance training in the UK, the USA, and worldwide. As a trusted Pharmacovigilance Consultant in USA, he is regularly invited to deliver keynote presentations at scientific conferences, promoting best practice, regulatory compliance, and excellence in drug safety.
Professor Saad Shakir
MB ChB, LRCP&S FRCP FISPE MRCGP
Global Drug Safety Consultancy & Pharmacovigilance Consultant USA
Saad Shakir is a highly respected Pharmacovigilance Consultant in USA, with an established international reputation in pharmacovigilance and pharmacoepidemiology across Europe and beyond. He delivers expert Pharmacovigilance Training in the UK, the USA, and internationally, supporting professionals and organisations seeking regulatory excellence, compliance, and best practice in drug safety. Saad has held senior leadership roles across 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.
In June 2025, Saad founded his independent consultancy, Adroit Vigilance, providing specialist pharmacovigilance consultancy, advanced training programmes, and strategic drug safety expertise. As an experienced Pharmacovigilance Consultant in USA, he supports organisations operating within US and global regulatory environments, helping to strengthen pharmacovigilance systems, enhance compliance standards, and implement robust risk management strategies.
Our Services
Drug safety services are vital for protecting patient wellbeing and maintaining trust in healthcare systems worldwide. A Pharmacovigilance Consultant in USA plays a key role in this process by overseeing the ongoing monitoring and evaluation of adverse drug reactions, conducting thorough risk assessments, and implementing effective risk minimisation strategies in line with US, EU, and international regulatory requirements.
By systematically collecting, analysing, and interpreting safety data, a Pharmacovigilance Consultant in USA helps identify potential medicine-related risks early, supporting informed clinical decision-making and proactive regulatory action. High-quality pharmacovigilance training in the UK, the USA, and internationally is equally essential, equipping professionals with the knowledge and practical expertise needed to ensure the safe use of medicines, prevent misuse, and uphold best practice in pharmacovigilance.
With a strong focus on patient safety, regulatory compliance, and therapeutic effectiveness, pharmacovigilance and drug safety services contribute to improved patient outcomes and reinforce long-term confidence 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 Pharmacovigilance Consultant in USA, we actively engage in international collaborative projects aimed at advancing pharmacovigilance standards and enhancing patient safety. These initiatives foster innovation within the field, promote regulatory best practice, and support improved patient outcomes across the USA, Europe, and globally.
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 Pharmacovigilance Consultant in USA, for consultancy support or speaking engagements, including pharmacovigilance training in the UK, USA, or internationally, please complete the enquiry form. For urgent matters, Saad can be contacted directly using the details below; however, response times may vary due to international travel commitments.
To help us assist you effectively, please provide a clear overview of your requirements and desired outcomes. Alternatively, you are welcome to get in touch via email or telephone to arrange a consultation or bespoke training session with a Pharmacovigilance Consultant in USA.