Specialist Pharmacovigilance Consultant Frankfurt
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 Frankfurt
Pharmacovigilance Consultant Frankfurt
Pharmacovigilance Consultant Frankfurt
Professor Saad Shakir is a leading authority in pharmacoepidemiology and drug safety, with extensive international experience in pharmacovigilance, regulatory compliance, and risk management. Through Pharmacovigilance Training UK, he provides specialist programmes and acts as a Pharmacovigilance Consultant in Frankfurt, offering tailored strategic support to pharmaceutical companies, healthcare organisations, and regulators across Germany, the UK, and globally.
His distinguished career includes senior positions within the UK regulatory system, at GlaxoSmithKline, and other international life sciences organisations, followed by his role as Director of the Drug Safety Research Unit in Southampton. In June 2025, he established his independent consultancy, delivering expert Pharmacovigilance Consultant in Frankfurt services alongside bespoke international training solutions.
Professor Shakir assists organisations in navigating complex drug safety challenges, including risk management planning, regulatory submissions, product withdrawals, and the design and implementation of large-scale pharmacovigilance systems. His teaching blends clinical expertise with advanced epidemiological methods, supporting post-authorisation safety studies, real-world evidence generation, and robust risk minimisation strategies in line with EU, UK, and global regulatory standards.
He also provides strategic oversight for safety submissions and regulatory responses, collaborating with multinational, mid-sized, and emerging life sciences companies. With extensive experience liaising with regulatory authorities and international institutions, he regularly contributes to Safety Advisory Boards and Data Safety Monitoring Committees.
A prolific academic, Professor Shakir has published extensively in peer-reviewed journals, book chapters, and conference proceedings on pharmacovigilance, pharmacoepidemiology, and drug safety risk management.
Committed to advancing global medicine safety standards, he continues to deliver high-level programmes and international training, sharing best practice while providing specialist Pharmacovigilance Consultant in Frankfurt services at scientific and regulatory events worldwide.
Professor Saad Shakir
MB ChB, LRCP&S FRCP FISPE MRCGP
Global Drug Safety Consultancy & Pharmacovigilance Consultant Frankfurt
Pharmacovigilance Consultant Frankfurt
Saad Shakir is a highly regarded expert in pharmacoepidemiology and drug safety, internationally recognised for his expertise in pharmacovigilance, regulatory compliance, and medicine safety across Germany, the UK, and global markets. Through Pharmacovigilance Training UK, he provides specialist consultancy and acts as a Pharmacovigilance Consultant in Frankfurt, delivering advanced training programmes across Europe. His work supports pharmaceutical companies, life sciences organisations, and regulatory authorities in achieving best practice, compliance, and operational excellence in drug safety.
Professor Shakir’s distinguished career includes senior leadership roles within the UK regulatory system, at GlaxoSmithKline, and other international life sciences organisations, followed by his role as Director of the Drug Safety Research Unit in Southampton. With extensive experience across regulatory, commercial, and academic sectors, he possesses in-depth knowledge of UK, EU, US, and global regulatory frameworks, enabling him to advise organisations across Europe and worldwide with confidence.
In June 2025, Professor Shakir founded his independent consultancy, Adroit Vigilance, offering expert Pharmacovigilance Consultant in Frankfurt services alongside advanced professional training and strategic drug safety support. Through Pharmacovigilance Training UK, he delivers tailored programmes designed to strengthen internal systems, enhance regulatory compliance, and implement robust risk management strategies aligned with UK, EU, US, and international standards.
Our Services
Ensuring the safety of medicines is essential for protecting patients and maintaining trust in healthcare systems. Pharmacovigilance Training UK offers expert support from a specialist Pharmacovigilance Consultant in Frankfurt, alongside comprehensive training programmes delivered across Europe. These sessions provide organisations with the skills and knowledge to monitor adverse drug reactions, conduct structured risk assessments, and implement effective risk minimisation strategies in line with regulatory requirements across the UK, EU, US, and other international jurisdictions.
Through the systematic collection, analysis, and interpretation of safety data, participants can identify potential medicine-related risks early. This evidence-based approach supports informed clinical decisions and enables timely regulatory interventions. Healthcare and life sciences professionals gain practical expertise to ensure the safe and appropriate use of medicines, reduce misuse, and maintain high standards of pharmacovigilance practice.
With a strong emphasis on patient safety, regulatory compliance, and therapeutic effectiveness, programmes led by a specialist Pharmacovigilance Consultant in Frankfurt help organisations enhance patient outcomes while reinforcing long-term confidence 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 work internationally to advance pharmacovigilance standards and safeguard patient safety. Through Pharmacovigilance Training UK, we provide expert guidance from a specialist Pharmacovigilance Consultant in Frankfurt, alongside a comprehensive pharmacovigilance training programme delivered across Europe. Our services drive innovation in drug safety, reinforce regulatory best practice, and ensure consistent compliance with frameworks across the UK, European Union, United States, and other global regulatory environments.
The European pharmacovigilance programme equips organisations to implement robust safety monitoring systems, enhance risk management processes, and support evidence-based regulatory decision-making. By sharing practical insights and international expertise, the programme enables healthcare and life sciences professionals to improve patient outcomes while maintaining the highest standards of drug safety across UK, European, US, and worldwide 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 authority in pharmacoepidemiology, for professional consultancy, speaking engagements, or a pharmacovigilance training programme across Europe, please complete the enquiry form provided. For urgent requests, Professor Shakir can also be contacted directly, although response times may vary due to international commitments.
To ensure the most effective support, we recommend providing clear and detailed information about your objectives and specific requirements. Alternatively, you may contact us by email or telephone to arrange a consultation or a bespoke European pharmacovigilance course delivered by an experienced specialist in drug safety and a recognised Pharmacovigilance Consultant in Frankfurt.