Specialist Pharmacovigilance Consultant Berlin
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 Berlin
Pharmacovigilance Consultant Berlin
Pharmacovigilance Consultant Berlin
Professor Saad Shakir is a recognised 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 Berlin, offering tailored strategic support to pharmaceutical companies, healthcare organisations, and regulators across Germany, the UK, and internationally.
His distinguished career includes senior positions within the UK regulatory system, GlaxoSmithKline, and other global life sciences organisations, before serving as Director of the Drug Safety Research Unit in Southampton. In June 2025, he established his independent consultancy, providing expert Pharmacovigilance Consultant in Berlin services alongside bespoke international training solutions.
Professor Shakir assists organisations in tackling complex drug safety challenges, including risk management planning, regulatory submissions, product withdrawals, and the design and implementation of large-scale pharmacovigilance systems. His teaching integrates 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 offers 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 bodies, he regularly contributes to 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.
Committed to advancing global medicine safety standards, he continues to deliver high-level programmes and international training, sharing best practices while providing expert Pharmacovigilance Consultant in Berlin services at scientific and regulatory events worldwide.
Professor Saad Shakir
MB ChB, LRCP&S FRCP FISPE MRCGP
Global Drug Safety Consultancy & Pharmacovigilance Consultant Berlin
Pharmacovigilance Consultant Berlin
Saad Shakir is a highly regarded expert in pharmacoepidemiology and drug safety, internationally recognised for his expertise in pharmacovigilance, regulatory governance, and medicine safety across Europe, the UK, and global markets. Through Pharmacovigilance Training UK, he provides specialist consultancy and acts as a Pharmacovigilance Consultant in Berlin, while delivering advanced pharmacovigilance training programmes across Europe. His work supports pharmaceutical companies, life sciences organisations, and regulatory bodies in achieving best practice, regulatory 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 global life sciences organisations, followed by his appointment as Director of the Drug Safety Research Unit in Southampton. His experience spans regulatory, commercial, and academic sectors, with in-depth knowledge of UK, EU, US, and international regulatory frameworks, enabling him to advise organisations across Europe and worldwide with confidence.
In June 2025, Professor Shakir launched his independent consultancy, Adroit Vigilance, providing expert Pharmacovigilance Consultant in Berlin services alongside advanced professional training and strategic drug safety support. Through Pharmacovigilance Training UK, he offers comprehensive programmes to help organisations strengthen internal systems, enhance regulatory compliance, and implement robust risk management strategies aligned with UK, EU, US, and international standards.
Our Services
Ensuring medicine safety is essential for protecting patient wellbeing and maintaining trust in healthcare systems. Pharmacovigilance Training UK provides expert guidance from a specialist Pharmacovigilance Consultant in Berlin, alongside comprehensive pharmacovigilance training programmes delivered across Europe. These programmes equip organisations with the knowledge and practical skills to monitor adverse drug reactions, carry out structured risk assessments, and implement effective risk minimisation strategies in line with regulatory requirements across the UK, EU, US, and other international jurisdictions.
Through systematic collection, analysis, and interpretation of safety data, participants can identify potential medicine-related risks early. This evidence-based approach supports informed clinical decision-making and enables timely regulatory interventions where necessary. Healthcare and life sciences professionals gain hands-on expertise to promote the safe and appropriate use of medicines, reduce misuse, and uphold high standards of pharmacovigilance practice.
With a strong focus on patient safety, regulatory compliance, and therapeutic effectiveness, programmes led by a specialist Pharmacovigilance Consultant in Berlin 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 engage in international collaborations to advance pharmacovigilance standards and safeguard patient safety. Through Pharmacovigilance Training UK, we provide specialist guidance from an experienced Pharmacovigilance Consultant in Berlin, alongside a comprehensive pharmacovigilance training programme delivered across Europe. Our services support innovation in drug safety, reinforce regulatory best practice, and promote consistent compliance with frameworks across the UK, European Union, United States, and other global regulatory environments.
The European pharmacovigilance programme equips organisations with the expertise to implement robust safety monitoring systems, strengthen risk management processes, and support evidence-based regulatory decision-making. By sharing practical insights and international experience, 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 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 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, though 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 Berlin.