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Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Pharmacovigilance (GVP)
4.1
★★★★★
93% Recommended
Updated 2025
15 hours
120 active users
20 points
If you'd like to swap a course or add additional courses, simply let us know — Reach out to us and we’ll customize a learning path tailored to your training needs.
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1 x Pharmacovigilance (GVP)
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Each course includes:
Fully compliant
This course meets the required standard for basic GCP training, allowing learners to work on clinical trials. Learners also receive 6 Continuing Professional Development (CPD) Points awarded by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certified
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from database, re-sitting the exam doesn’t mean taking the same questions again and again.
Affordable
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
Time-saving
Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training.
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About
The Pharmacovigilance (PV) Learning Path is a comprehensive, structured program designed to build end-to-end expertise in drug and medical device safety in alignment with global regulatory expectations. This learning path covers the complete pharmacovigilance lifecycle—from adverse event collection and case processing to signal detection, risk assessment, audits, and regulatory compliance across multiple regions.
Learners will gain a strong understanding of international PV regulations, safety documentation, inspection readiness, and post-marketing surveillance requirements. The curriculum is designed to bridge theory with real-world application, ensuring learners are prepared to support pharmacovigilance operations in pharmaceutical, biotechnology, and medical device organizations.
This learning path is suitable for beginners entering pharmacovigilance, as well as professionals in clinical research, regulatory affairs, quality, and safety roles who want to strengthen or expand their PV capabilities. Upon completion, learners will be equipped to contribute effectively to patient safety, regulatory submissions, audits, and global safety systems.
Who Should Enrol?
- Pharmacovigilance and drug safety associates involved in case processing and safety reporting.
- Clinical research professionals working with clinical trial safety data and reporting requirements.
- Regulatory affairs and quality/compliance professionals ensuring adherence to global safety regulations.
- Life sciences graduates and career switchers aiming to enter pharmacovigilance and drug safety roles.
What you will learn
Understand end-to-end pharmacovigilance (PV) processes for drugs and medical devices, including safety data collection, assessment, and reporting.
Learn global regulatory requirements and Good Pharmacovigilance Practices (GVP) to ensure compliance across different regions.
Develop practical skills in safety case handling, signal detection, risk management, and audit/inspection readiness.
Gain knowledge of pharmacovigilance operations, regulatory submissions, and safety surveillance systems used in real-world industry settings.
Courses Included
Covers core pharmacovigilance concepts including adverse event reporting, case processing, safety documentation, and the role of PV in patient protection
4 hours
4 points
Provides an in-depth overview of global PV regulatory frameworks, including ICH guidelines, FDA, EMA, and international reporting requirements
3 hours3 points
Teaches methodologies for identifying safety signals, evaluating benefit–risk profiles, and managing emerging safety concerns throughout the product lifecycle
3 hours4 points
Covers medical device vigilance requirements, post-market surveillance, adverse event reporting, and global regulatory obligations under device regulations
4 hours4 points
Covers best practices for safe, compliant storage of pharmaceutical products, including temperature control, inventory management, and regulatory requirements.
3 hours3 pointsOur Certified Customers
Learner Rating & Reviews
4.7
★★★★★★
Average Rating
536 global ratings
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Frequently Asked Questions
- PV and Drug Safety Associates
- Clinical Research Professionals
- Regulatory Affairs Professionals
- Quality and Compliance Teams
- Life Sciences Graduates & Career Switchers
- End-to-end PV knowledge across drugs and devices
- Global regulatory compliance understanding
- Practical, inspection-ready skills
- Career-aligned learning for PV roles
- Certificate of completion
On completion, learners will be equipped to support pharmacovigilance operations, audits, regulatory submissions, and safety risk management in global pharmaceutical and medical device environments.
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