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Pharmacovigilance & Safety Writing Specialist Learning Path
4.7
★★★★★
97% Recommended
Updated 2025
18 hours
0 active users
18 points
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Each course includes:
Fully compliant
This learning path is aligned with EU GVP Modules I–XVI, ICH E2A–E2F guidelines, EMA and FDA pharmacovigilance reporting requirements, ALCOA+ data integrity standards, and ICH E2C(R2) for periodic safety reporting — providing comprehensive operational and writing competency for PV professionals. Learners receive Continuing Professional Development (CPD) Points awarded by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom.
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 a database, re-sitting the exam does not 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 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 & Safety Writing Specialist Learning Path is designed to develop professionals into competent, specialist practitioners capable of managing and writing across the full spectrum of pharmacovigilance and drug safety documentation. Covering PV fundamentals, ICSR case processing and narrative writing, signal detection and risk assessment, PSUR and PBRER medical writing, aggregate reporting frameworks, literature monitoring, and AI applications in pharmacovigilance, this programme provides a structured pathway from PV operational competency through to specialist safety writing expertise.
Participants will develop the ability to produce regulatory-grade PV documentation — from individual case narratives and signal summaries through to complex periodic aggregate reports — in compliance with EU GVP modules, ICH E2 series guidelines, and EMA and FDA reporting expectations. The programme also equips professionals with forward-looking competency in AI-driven PV tools that are reshaping case processing and safety surveillance operations.
How this differs from the Foundations of Medical Writing Learning Path
The Pharmacovigilance & Safety Writing Specialist Learning Path is designed for professionals who have already established foundational GCP, GVP, and documentation knowledge and are ready to specialise in PV writing operations. It focuses specifically on the full range of PV document types — ICSRs, signal reports, PSURs, PBRERs, literature monitoring records, and CAPA reports — and builds the depth of regulatory and writing competency required for a specialist PV or safety writing role.
In comparison, the Foundations of Medical Writing Learning Path provides the entry-level regulatory context and introductory writing skills that serve as the prerequisite for this specialist programme. Professionals completing the Foundations path are recommended to progress to this Specialist path as their next development step.
Who should enrol:
- Pharmacovigilance Associates
- Drug Safety Specialists
- Medical Writers
- Clinical Research Professionals
- Regulatory Affairs Professionals
- Life Science Graduates
- and individuals seeking a career in drug safety and safety writing
What you will learn
Understand global pharmacovigilance regulations, reporting requirements, and compliance standards.
Master adverse event processing, case assessment, and narrative writing techniques.
Develop expertise in aggregate safety reporting, signal detection, and risk management practices.
Enhance medical and regulatory writing skills for safety documentation and benefit-risk evaluation.
Courses Included
Core pharmacovigilance fundamentals — ADR classification, causality assessment, EU and FDA spontaneous reporting requirements, and MAH PV obligations
3 hours
2 points
End-to-end ICSR management — case receipt, triage, medical coding, causality assessment, and regulatory narrative writing for expedited and non-expedited reports
3 hours2 pointsPSUR preparation and content requirements — EURD timelines, line listings, summary tabulations, and medical writing of the benefit-risk evaluation section
2 hours3 points
PBRER structure and ICH E2C(R2) alignment — integrated summary of safety, benefit-risk conclusions, and regulatory submission writing for periodic aggregate reports
2 hours3 pointsSystematic literature monitoring under GVP Module VI — search strategy design, triage, case identification, and documenting literature screening outcomes
2 hours3 points
AI applications transforming PV writing and operations — automated case processing, AI-assisted narrative generation, signal detection algorithms, and regulatory considerations for AI-driven PV tools
2 hours3 pointsOur Certified Customers
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Frequently Asked Questions
- Pharmacovigilance Associates and Drug Safety Specialists progressing into writing roles
- PV Medical Writers and Safety Writers in pharmaceutical and CRO organisations
- Regulatory Affairs Associates with responsibility for safety reporting documents
- PSUR and PBRER authors and coordinators in MAH teams
- Signal management and risk assessment specialists
- PV auditors and quality professionals involved in CAPA and deviation documentation
- Healthcare professionals transitioning into specialist pharmacovigilance writing roles
- Professionals who have completed the Foundations of Medical Writing Learning Path and are seeking specialist PV writing development
- Apply core pharmacovigilance principles and global regulatory frameworks to produce accurate, compliant ICSR case narratives and expedited safety reports in line with EU GVP module requirements and ICH E2A guidelines.
- Conduct signal detection, disproportionality analysis, and risk assessment activities, and communicate findings through written signal evaluation reports and risk minimisation documentation aligned with PRAC and EMA expectations.
- Prepare and write PSUR and PBRER aggregate safety reports in compliance with EURD timelines and ICH E2C(R2) structure, including integrated benefit-risk evaluation sections and supporting line listings and summary tabulations.
- Manage literature monitoring programmes under GVP Module VI, produce written CAPA and deviation reports to regulatory standards, and apply AI-driven tools to enhance the efficiency and quality of pharmacovigilance writing operations.
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