Pharmacovigilance and Drug Safety (GVP) Corporate Training
Master adverse event processing, signal detection, and GVP compliance with guided drug-safety labs.
Edstellar, a corporate training company, delivers instructor-led pharmacovigilance training that helps drug safety, quality, regulatory, and clinical teams process adverse event cases, detect safety signals, manage risks, and meet Good Pharmacovigilance Practice obligations across global markets.
Instructor-led group trainingVirtual / on-site / off-site10 languagesDelivered inEnglish, Spanish, Mandarin, German, Arabic, Portuguese, Hindi, French, Japanese, Italian100+ countriesWe have delivered inUnited States, United Kingdom, India, Canada, Germany, France, Netherlands, UAE, Saudi Arabia, Singapore, Australia, Japan, Brazil, South Africa and 90+ more countries
How we build a signal-ready drug safety team
The Edstellar DRUG SAFETY & PHARMACOVIGILANCE Capability Model
Diagnose safety maturity
Assess current case processing, signal workflows, and GVP compliance against EU, US, and ICH expectations.
Standardize case and signal processes
Align adverse event capture, causality assessment, and signal triage to one consistent, auditable operating model.
Practice in guided labs
Process cases, run disproportionality analyses, and draft risk documents in sandbox safety workflows.
Measure signal and compliance quality
Check case completeness, signal detection performance, and reporting timeliness against regulatory benchmarks.
Scale across products and markets
Extend validated pharmacovigilance processes to new products, affiliates, and emerging regulatory regions.
Need more than one program?Get a group quote
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Program Overview: What is Pharmacovigilance and Drug Safety (GVP)?
Pharmacovigilance & Drug Safety (GVP) is Edstellar's instructor-led program for drug safety and pharmacovigilance teams. Participants work through the GVP framework, adverse event capture and case processing, narrative writing, signal detection and data mining, risk management plans, and global safety databases and submissions. The focus stays on compliant, defensible safety operations.
Across 24 hours, participants process adverse event cases from intake to narrative, practice signal detection on realistic datasets with instructor review, and draft risk management sections under GVP expectations. Aggregate reporting and regulatory submission exercises run on realistic timelines and formats. The program closes with an end-to-end drug safety operations review.
Safety teams get overwhelmed by case volume while signals hide in the backlog: late reports, weak narratives, and detection that runs after the problem. This program teaches teams to run the full workflow with discipline, from capture to signal to submission, so safety signals surface early and reports stand up to inspection.
The closing review is a full operations assessment: the team audits a simulated safety operation across case processing, signal detection, risk management, and submissions, then presents findings and fixes to the instructor. Diagnosing someone else's operation is what sharpens their eye for the gaps in their own.
Late or incomplete safety reporting draws regulatory action and erodes patient trust. This program gives pharmacovigilance officers, drug safety associates, quality and regulatory staff a working command of case processing, MedDRA coding, signal detection statistics, risk minimization, PSUR and PBRER authoring, and GVP inspections. Labs use realistic case scenarios so teams return able to process cases accurately, detect signals early, and defend their safety system to inspectors.
What's Included in this Workshop for Your Enterprise Teams
- 1
GVP and regulatory foundations
EU GVP modules, FDA expectations, ICH guidelines, and inspection triggers.
- 2
Case processing labs
Intake, triage, MedDRA coding, causality, and narrative writing practice.
- 3
Signal detection workshops
Disproportionality statistics, signal triage, and validation workflows.
- 4
Risk and aggregate reporting
RMPs, PSUR/PBRER authoring, and benefit-risk evaluation.
- 5
Inspection readiness drills
Mock GVP inspections, QPPV duties, and audit-trail reviews.
- Instructor-led sessions across virtual, onsite, or hybrid formats
- Guided drug-safety labs in sandbox safety workflows
- Course materials with GVP checklists and case templates
- Hands-on exercises using realistic adverse event scenarios
- Assessment of case processing and signal workflows
- Post-training support for implementation questions
Build your team's skills. Anywhere in the world.
Real-world use cases
from day one
Instructor-led training
for your teams
Delivered globally
in 100+ countries
Enterprise Training Solutions Customized for Your Company
One partner for instructor-led corporate training, delivered the way your teams work.
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Pharmacovigilance and Drug Safety (GVP) Course Topics and Program Outline
A 24-hour instructor-led program covering GVP foundations, adverse event case processing, signal detection, risk management plans, aggregate reporting, and inspection readiness, with guided labs in every module.
Built by Edstellar with pharmacovigilance practitioners
Built by drug safety physicians and pharmacovigilance consultants who run GVP-compliant safety systems in production, shaped around your stack and use cases.
We review your case volumes, signal workflows, and GVP gaps so the program targets your real safety risks.
Master regulations, case processing, and MedDRA coding with instructor demos drawn from real safety databases.
Process cases, run signal analyses, and draft risk documents in sandboxes that mirror live safety operations.
Close with a capstone safety operations review for your products, reviewed by the instructor.
Leave with validated case and signal workflows your team can run the week after training.
Delivered as
Delivery is instructor-led and hybrid-ready. Lab scenarios adapt to your product portfolio, safety systems, and regulatory markets.
Map GVP module obligations to roles in a sample safety organization.
learna)History and purpose of pharmacovigilance
b)EU GVP modules: structure and key obligations
c)FDA and ICH pharmacovigilance expectations
d)QPPV role, responsibilities, and oversight
e)Pharmacovigilance system master file essentials
Process sample adverse event reports into coded, narrative-ready cases.
learna)Case intake: spontaneous, literature, and study sources
b)Triage, validity assessment, and seriousness criteria
c)MedDRA coding principles and conventions
d)Causality assessment methods
e)Clinical narrative writing for regulatory cases
Run disproportionality analyses on a sample dataset and triage the findings.
practicea)Signal definition and the signal management lifecycle
b)Disproportionality: PRR, ROR, and Bayesian methods
c)Designing data-mining runs and thresholds
d)Signal triage, prioritization, and validation
e)Documenting signal decisions for inspection
Draft RMP sections and a PSUR summary from a product case study.
practicea)RMP structure: safety specification and pharmacovigilance plan
b)Risk minimization measures and effectiveness checks
c)PSUR/PBRER: purpose, format, and writing discipline
d)Benefit-risk evaluation techniques
e)Coordinating inputs across safety, clinical, and regulatory
Prepare E2B-compliant case submissions for simulated regulatory gateways.
applya)EudraVigilance: reporting rules and data quality
b)FAERS and FDA expedited reporting timelines
c)ICH E2B data standards for case exchange
d)Expedited vs periodic reporting decisions
e)Managing reporting across affiliates and partners
Execute and defend a complete drug safety cycle in an instructor-reviewed simulation.
applya)Case processing surge: triage and quality control plan
b)Signal detection run and validation workflow
c)Risk management and aggregate reporting decisions
d)Regulatory submission and timeline compliance
e)Mock GVP inspection and defense of the safety system
Customize this program tailored to your team?
Tell us your training needs: what your team already works with, the level they’re at, and the topics you want them to focus on. We’ll adjust the modules, duration and hands-on labs, and send you a customized outline for your group.
Key Skills and Outcomes Your Team Will Gain
By the end of this program, your team will run pharmacovigilance operations that meet GVP obligations and catch safety signals early.
Apply GVP obligations in practice
Translate EU GVP modules and FDA expectations into daily safety operations and oversight routines.
Process adverse event cases
Triage, code in MedDRA, assess causality, and write regulatory-grade narratives under reporting timelines.
Detect and validate safety signals
Run disproportionality analyses, triage findings, and document signal decisions for inspection.
Author risk management plans
Draft RMPs with safety specifications, pharmacovigilance plans, and risk minimization measures.
Write aggregate safety reports
Produce PSUR/PBRER documents with disciplined benefit-risk evaluation and cross-functional inputs.
Submit to global safety databases
Prepare E2B-compliant submissions for EudraVigilance and FAERS within expedited timelines.
Defend GVP inspections
Present audit trails, signal records, and system documentation that satisfy regulatory inspectors.
Teams that Benefit from this Pharmacovigilance and Drug Safety (GVP) Group Training
This program is built for drug safety, pharmacovigilance, quality, regulatory, and clinical teams that own adverse event reporting and signal management. Content adapts to each cohort's products and systems so every team practices the workflows it owns.
Process cases accurately and on time
Safety associates learn intake, triage, MedDRA coding, and narrative writing so every case meets quality and timeline targets.
Workflow friction
- Case backlogs at quarter end
- Inconsistent coding conventions
- Weak narrative quality
How the program helps
- Triage cases faster and consistently
- Code in MedDRA with confidence
- Write inspection-ready narratives
Practice use cases
- case triage labs
- MedDRA coding drills
- narrative workshops
Catch safety signals before regulators do
Signal teams learn data mining, triage, and validation so emerging risks are detected, documented, and acted on early.
Workflow friction
- Noisy data-mining outputs
- Unclear validation thresholds
- Poor signal documentation
How the program helps
- Run reliable disproportionality analyses
- Triage signals with clear criteria
- Document decisions defensibly
Practice use cases
- data mining labs
- signal triage exercises
- validation workflows
Keep submissions and reports compliant
Regulatory staff learn reporting timelines, RMP and PSUR expectations, and database submissions so filings stay compliant across markets.
Workflow friction
- Missed reporting deadlines
- Inconsistent aggregate reports
- Multi-market complexity
How the program helps
- Meet expedited reporting timelines
- Author compliant RMPs and PSURs
- Navigate EudraVigilance and FAERS
Practice use cases
- timeline planning labs
- RMP drafting
- submission exercises
Prove the safety system works
QA teams learn GVP audit, PSMF maintenance, and inspection readiness so the pharmacovigilance system passes scrutiny.
Workflow friction
- Audit findings on signal work
- Outdated safety documentation
- Weak CAPA follow-through
How the program helps
- Audit safety processes effectively
- Maintain the PSMF correctly
- Lead mock inspections
Practice use cases
- GVP audit drills
- PSMF workshops
- mock inspections
Cohorts can mix functions or focus on one; labs adapt to your safety database, products, and markets.
Prerequisites: Participants benefit most from familiarity with pharmaceutical, clinical, or healthcare operations. No prior pharmacovigilance or MedDRA experience is required; the program builds from GVP foundations up to signal management. Content adapts to each cohort's products, safety systems, and regulatory markets.
Safety Associate to Pharmacovigilance Lead
The program moves from GVP foundations and case processing through signal detection and reporting to inspection-ready safety leadership.
One program that grows with drug safety careers, from case processing basics to safety system leadership.
Mixed cohort, or several teams at once?
We can tailor the training to different teams, roles, and experience levels within the same program.
Certificate of Training Completion.
On successful completion, employees receive an Edstellar course completion certificate, recognizing their commitment to ongoing learning and professional development. It validates the skills they have built and motivates them to keep growing and contribute to organizational success.
Earned, not attended. Awarded on completion of all hands-on labs and the capstone project.
Training Delivery Modes: Virtual, Onsite and Hybrid
Choose the format that fits your safety teams: fully virtual labs, onsite sessions at your office, or a hybrid blend.
Hybrid Training
Blend virtual theory with onsite workshop days, so teams learn GVP frameworks remotely and practice case work together.
- Virtual sessions for GVP and regulations
- Onsite labs for case and signal work
- One cohort, one consistent curriculum
- Recorded sessions for shift coverage
Onsite Training
Run the full program at your office or safety center, with labs mapped to your safety database and product portfolio.
- Training at your safety center
- Labs using your case workflows
- Cross-team participation
- Direct coaching on your processes
Live Virtual Training
Join live from any site with instructor-led sessions and sandbox labs for case processing and signal analysis.
- Live instructor-led virtual sessions
- Sandbox safety workflow labs
- Breakout rooms for team exercises
- Digital materials and templates
Need a training format that works for your team?
Full days, half days across weeks, or split by module. Tell us the delivery window and we schedule the cohort around it.
Frequently Asked Questions
Share your team size, products, and markets through the request form and we will send a tailored proposal with schedule options.
Yes. A discovery call maps your case volumes, systems, and GVP gaps so the program targets your safety needs.
Yes. Live virtual sessions include sandbox labs for case processing, signal analysis, and report drafting.
Yes. Onsite delivery maps labs to your safety database, products, and reporting workflows.
The program runs 24 instructor-led hours, typically over three days, with guided labs in every module.
Question not answered here?
Put it in the request. A training specialist answers it directly, within one business day.
Where this Training Fits in Your Team's learning path.
Drug safety work starts long before launch, so this path begins with GCP and approval. Pharmacovigilance then takes over once the product is used widely, and real-world evidence lets your team study safety and value in routine clinical practice.
Why Choose Edstellar as Your Pharmacovigilance and Drug Safety (GVP) Training Provider
Edstellar delivers pharmacovigilance training shaped around your products, safety database, and regulatory markets, with labs that mirror real safety operations.
EXPERT TRAINERS
YEARS DELIVERING
ORGANIZATIONS TRAINED
CERTIFIED
Tailored
Curriculum adapts to your product portfolio, safety systems, case volumes, and regulatory markets.
Proven Methodology
A learn-practice-apply arc moves teams from GVP foundations to inspection-ready safety operations.
Practice-Based Learning
Guided case, signal, and reporting labs build muscle memory before live safety decisions.
Expert Trainers
Drug safety physicians and PV consultants with production safety system experience lead every session.
Global Scale
We train drug safety and regulatory teams across affiliates, time zones, and markets worldwide.
Measurable Outcomes
Quality checks on case completeness, signal documentation, and reporting timeliness show progress.
Develop Drug Safety Workflows From Case Intake to Signal Review
Edstellar connects pharmacovigilance foundations with disciplined case processing and safety analysis. Participants prepare adverse event narratives, explore signals in sample data, and develop risk-management and aggregate reporting documents. Simulated submissions and an operations review provide evidence of learning, with feedback on case completeness, analytical reasoning, and documentation across the safety cycle.
- Step 01
Consult
We examine clinical or pharmaceutical experience, safety responsibilities, and gaps in case narratives, signal analysis, or submissions to establish appropriate pharmacovigilance learning priorities.
- Step 02
Plan
We progress from GVP roles and adverse event processing to signal detection, risk management, aggregate reports, and simulated safety database submissions.
- Step 03
Align
We align drug safety expertise with the cohort's case-processing and oversight responsibilities, allowing foundational support where pharmacovigilance terminology or coding practices are unfamiliar.
- Step 04
Customize
We adapt fictional adverse event cases and product safety datasets to relevant therapeutic contexts, keeping personal health information out of training exercises.
- Step 05
Execute
Participants construct case narratives, run disproportionality analyses, draft RMP and PSUR sections, and prepare simulated submissions, receiving feedback on interpretation and record consistency.
- Step 06
Evaluate
We assess the safety operations review for complete cases, justified signal triage, coherent risk-management documentation, and traceable findings across the simulated reporting cycle.
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→OD consulting
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→Managed training services
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→Coaching solutions
Executive and manager coaching that keeps skills in use.
Start an RFP shaped to your needs.
Answer three quick questions about team size, scope, and how often you need the program run, then send the request from the last step. Everything you choose travels with it, so you only fill this in once.
How many team members need training?
Pharmacovigilance & Drug Safety (GVP) Training Training Packages & Pricing
Where L&D holds an annual budget, license packages price the whole year at once instead of raising a purchase order per workshop. Hours and licenses are pooled across teams, programs and locations, so unused capacity is not stranded in one department.
Starter
120
trainee licenses64 hours of group training
Tailored for SMBs
Growth
320
trainee licenses160 hours of group training
Ideal for growing SMBs
Enterprise
800
trainee licenses400 hours of group training
Designed for large corporations
Custom
Unlimited
trainee licensesDuration set by the rollout
Multi-region and multi-year
Training Packages & Pricing
Choose the training format that works for your team. Pricing is customized based on your requirements, cohort size, and delivery needs.
Request Pharmacovigilance and Drug Safety (GVP) Training for Your Team
Share your team size, product portfolio, safety systems, and timelines to receive a tailored training proposal with schedule options.