Specialist Pharmacovigilance Training Germany
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 Training Germany
Pharmacovigilance Training Germany
Pharmacovigilance Training Germany
Professor Saad Shakir is a highly respected expert in pharmacoepidemiology and drug safety, internationally recognised for his leadership in pharmacovigilance, regulatory governance, and risk management. He delivers specialist pharmacovigilance training in Germany, supporting pharmaceutical companies, regulatory authorities, and global healthcare organisations operating across European and international markets.
His distinguished career includes senior 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 an independent consultancy, providing expert drug safety advisory services and advanced pharmacovigilance training worldwide, including tailored programmes for organisations in Germany.
Through pharmacovigilance training in Germany, Professor Shakir advises on complex and high-risk drug safety challenges such as product withdrawals, risk management and mitigation strategies, regulatory submissions, and large-scale pharmacovigilance systems. He combines deep clinical insight with advanced epidemiological methodologies to support PASS studies, real-world evidence generation, post-authorisation safety studies, and robust risk minimisation plans. His work is underpinned by extensive knowledge of EU, UK, and US regulatory frameworks.
Professor Shakir provides strategic oversight for safety submissions and regulatory responses, working closely with multinational pharmaceutical companies as well as mid-sized and emerging life sciences organisations operating within Germany and across Europe. His experience 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 authority, he has authored numerous peer-reviewed journal articles, book chapters, and conference abstracts covering pharmacovigilance, pharmacoepidemiology, and drug safety 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 training in Germany, across Europe, and internationally. He is a regular 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
Pharmacovigilance Training Germany
Saad Shakir is a highly respected pharmacoepidemiology and drug safety specialist, internationally recognised for his expertise in pharmacovigilance, pharmacoepidemiology, and regulatory drug safety across the UK, the United States, Europe, and global markets. He delivers specialist consultancy services and pharmacovigilance training in Germany, supporting pharmaceutical companies, life sciences organisations, and regulatory stakeholders in achieving regulatory compliance, operational excellence, and best practice in drug safety.
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. This background provides extensive experience across regulatory, commercial, and academic environments, supported by in-depth knowledge of EU, UK, US, and international regulatory frameworks relevant to organisations operating in Germany.
In June 2025, Saad established his independent consultancy, Adroit Vigilance, delivering expert pharmacovigilance advisory services, advanced professional training programmes, and strategic drug safety support. Through pharmacovigilance training in Germany, he works closely with organisations to strengthen pharmacovigilance systems, enhance regulatory compliance, and implement robust risk management strategies aligned with EU, UK, US, and global regulatory requirements.
Our Services
Drug safety services play a critical role in protecting patient wellbeing and sustaining confidence in healthcare systems. Pharmacovigilance training in Germany supports organisations in developing the expertise required to monitor and evaluate adverse drug reactions, conduct robust risk assessments, and implement effective risk minimisation strategies in line with EU, UK, US, and international regulatory requirements.
Through the systematic collection, analysis, and interpretation of safety data, pharmacovigilance training in Germany enables the early identification of medicine-related risks, supporting evidence-based clinical decision-making and timely regulatory action. High-quality training equips healthcare and life sciences professionals with the practical knowledge needed to ensure the safe and appropriate use of medicines, reduce the risk of misuse, and maintain best-practice standards in pharmacovigilance.
By placing patient safety, regulatory compliance, and therapeutic effectiveness at the centre of drug safety strategy, pharmacovigilance training in Germany contributes to improved patient outcomes and helps 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 leading authority in pharmacoepidemiology, we are actively involved in international collaborative programmes focused on advancing pharmacovigilance standards and strengthening patient safety. Through pharmacovigilance training in Germany, these initiatives drive innovation in drug safety and pharmacoepidemiology, promote regulatory best practice, and support consistent compliance across complex regulatory environments.
Our work in pharmacovigilance training in Germany contributes to the development of robust safety systems, improved risk management frameworks, and evidence-based regulatory decision-making. By sharing global expertise and practical insights, we help organisations enhance patient outcomes and uphold high standards of drug safety across Germany, Europe, and international 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, for specialist consultancy, speaking engagements, or pharmacovigilance training in Germany, please complete the enquiry form. For time-sensitive matters, Professor Shakir can also be contacted directly using the details provided; however, response times may vary due to international professional commitments.
To enable the most effective support, we recommend outlining your objectives and requirements in as much detail as possible. Alternatively, you may contact us by email or telephone to arrange a consultation or a bespoke pharmacovigilance training Germany programme delivered by an experienced pharmacoepidemiology specialist.