Specialist Pharmacovigilance Consultant New York
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 Consultant New York
Pharmacovigilance Consultant New York
Pharmacovigilance Consultant New York
Professor Saad Shakir is a recognised authority in pharmacoepidemiology and drug safety, with extensive international experience in pharmacovigilance, regulatory governance, and risk management. Through Pharmacovigilance Training UK, he provides specialist programmes and serves as a Pharmacovigilance Consultant in New York, offering tailored guidance to pharmaceutical companies, regulators, and healthcare organisations across the US, UK, Europe, and globally.
His distinguished career includes senior leadership roles at the UK regulatory authority, GSK, and RPR, before his appointment as Director of the Drug Safety Research Unit in Southampton. In June 2025, Professor Shakir launched his independent consultancy, delivering expert Pharmacovigilance Consultant in New York alongside advanced training programmes and bespoke international solutions.
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 combines clinical insight with advanced epidemiological methods, supporting post-authorisation safety studies, real-world evidence generation, and robust risk minimisation strategies in line with UK, EU, US, 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 the US, UK, and internationally. He has extensive experience liaising with 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 publications, including Drug Safety and Pharmacoepidemiology and Drug Safety.
Committed to advancing global medicine safety standards, Professor Shakir continues to deliver high-level programmes and international training, sharing best practices and providing expert Pharmacovigilance Consultant in New York at scientific and regulatory conferences worldwide.
Professor Saad Shakir
MB ChB, LRCP&S FRCP FISPE MRCGP
Global Drug Safety Consultancy & Pharmacovigilance Consultant New York
Pharmacovigilance Consultant New York
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 the US, UK, Europe, and global markets. Through Pharmacovigilance Training UK, he provides specialist consultancy and delivers expert Pharmacovigilance Consultant in New York, alongside leading pharmacovigilance courses across Europe. 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 comprehensive knowledge of UK, EU, US, and international regulatory frameworks, enabling him to confidently advise organisations across the US, Europe, and globally.
In June 2025, Saad established his independent consultancy, Adroit Vigilance, offering expert Pharmacovigilance Consultant in New York, advanced professional training, and strategic drug safety support. Through Pharmacovigilance Training UK, he delivers comprehensive pharmacovigilance programmes that help organisations strengthen their systems, improve regulatory compliance, and implement robust risk management strategies in line with UK, EU, US, and international requirements.
Our Services
Ensuring medicine safety is essential for protecting patient wellbeing and maintaining confidence in healthcare systems. Pharmacovigilance Training UK provides expert guidance from a leading Pharmacovigilance Consultant in New York, alongside comprehensive pharmacovigilance courses across Europe. 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, US, and international regulatory standards.
By systematically collecting, analysing, and interpreting 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 intervention where necessary. Healthcare and life sciences professionals gain practical expertise to promote the safe and appropriate use of medicines, prevent misuse, and maintain the highest standards of pharmacovigilance practice.
With a strong focus on patient safety, regulatory compliance, and therapeutic effectiveness, the pharmacovigilance programme, supported by a specialist Pharmacovigilance Consultant in New York, 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 guidance from an expert Pharmacovigilance Consultant in New York, alongside a comprehensive Pharmacovigilance Course across Europe. Our services support innovation in drug safety, reinforce regulatory best practice, and promote consistent compliance across UK, European, US, and global regulatory frameworks.
The Pharmacovigilance Course Europe equips organisations with the tools to establish robust pharmacovigilance systems, strengthen 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 uphold 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 expert in pharmacoepidemiology, for professional guidance from a Pharmacovigilance Consultant in New York, speaking engagements, or a Pharmacovigilance Course across Europe, please complete the enquiry form provided. For urgent enquiries, Professor Shakir can also be contacted directly using the details listed, though response times may vary due to international commitments.
To ensure the most effective and tailored support, we recommend providing clear and detailed information regarding 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.