Pharmacovigilance and adverse event reporting
A ready-made course you customise for your organisation, with a live session deck and two surveys. You only add the 17 details that are specific to your organisation.
- Length
- 40 min
- Lessons
- 6 lessons
- Frequency
- At induction + annual refresher
- Last reviewed
- 21 Oct 2026
Your team is about to launch a patient-support programme with an external nurse agency. The draft contract covers fees and data protection, but says nothing about adverse events
Try it: this is one of 32 interactive activities in the course.
What's included
Three pieces that work together
Copy once, get everything. Learners prepare on their own, you answer questions live, and the surveys tell you what stuck.
Self-paced course
Short lessons with real workplace scenarios, not walls of text.
- 6 lessons, about 40 minutes
- Scenario, accordion, sorting activity, process and quizzes
Live session deck
An AhaSlides presentation to run after the course, in person or online.
- 10 slides
- Poll, open-ended slides
- A closing slide for your contacts
Two surveys
Find out what landed, and whether people use it on the job.
- Post-course feedback, about 2 minutes
- 30-day check-in
- Anonymous by default
- Results feed your next refresher
Learning objectives
At the end of this course, learners can
Each objective and the lesson that covers it.
| ID | Objective | Source | Where it's covered |
|---|---|---|---|
| TO 149.0 | Achieve ≥ 80% on the final assessment | - | Whole course |
| LO 149.1.1 | Recognise an adverse event, a serious adverse event and the other safety observations that must be passed on | ICH E2A; ICH E2D(R1) | Lesson 1: What counts as an adverse event |
| LO 149.2.1 | Pass safety information on with the minimum information, within your company's deadline, knowing that the regulatory clock has started + your info | ICH E2D(R1) s.2.2, 5.2; GVP VI.B.7 | Lesson 2: Reporting routes and timelines |
| LO 149.3.1 | Explain why agreements with partners and vendors must cover safety reporting + your info | ICH E2D(R1) s.6.5 | Lesson 3: Safety data agreements |
| LO 149.4.1 | Describe what causality assessment is, and why reporting doesn't wait for it | ICH E2A; WHO-UMC | Lesson 4: Causality basics |
| LO 149.5.1 | Handle safety information from social media, conversations and events correctly + your info | ICH E2D(R1) s.4.3; GVP VI.B.1.1.4 | Lesson 5: Reporting from social media and the field |
Your part: what a template can't do for you
- Your workplace details: fill in the 17 highlighted fields so the course describes your own policies, contacts and locations.
- Records: record completion in your own LMS or record system.
Course outline
6 lessons, about 40 minutes
Minutes per lesson are an estimate, shared out by page count.
1What counts as an adverse event
4 pages
9 min
What counts as an adverse event
4 pages
2Reporting routes and timelines
3 pages
7 min
Reporting routes and timelines
3 pages
3Safety data agreements
2 pages
5 min
Safety data agreements
2 pages
4Causality basics
2 pages
5 min
Causality basics
2 pages
5Reporting from social media and the field
3 pages
7 min
Reporting from social media and the field
3 pages
6Final assessment
3 pages
7 min
Final assessment
3 pages
Live deck and surveys
10 slides to run live, two surveys to close the loop
Pink slides are interactive. Both surveys are anonymous; pink questions are written for this course.
Post-course feedback: 11 questions, about 2 min
- Overall rating 5 stars
- Relevant, realistic, right length, helpful activities agree/disagree grid
- What was most useful? multi-select
- Confidence before this course, and now 1-5 scale
- In the last month, did you hear any information that could have been an adverse event? multiple choice
- What stops people reporting? (choose the main one) multiple choice
- How confident are you that you could find the reporting form within two minutes? 1-5 scale
- In my team, reporting a possible adverse event is seen as part of the job, not a nuisance. 1-5 scale
- One thing we should change or add open text
- Would you recommend this course? NPS
30-day check-in
- Have you used what you learned since the course? multiple choice
- How confident are you today? Compare with day 1 1-5 scale
- Do you know where to find our adverse event reporting form or system and the safety team contact? yes / no / not sure
- A moment where the training helped, or where you weren't sure open text
- Which topics should the next refresher focus on? ranking
Results show whether people use the training on the job, not just whether they finished it.
Make it yours
17 fields to fill in, and you're ready
Everything else is done. These are the details only your organisation knows; each one is highlighted inside the course.
- Your safety reporting procedure or SOP
{{PV_PROCEDURE_NAME}} - Safety team contact
{{SAFETY_TEAM_CONTACT}} - Safety mailbox
{{SAFETY_MAILBOX}} - Safety phone
{{SAFETY_PHONE}} - E.g. within one business day
{{INTERNAL_AE_FORWARDING_TIMELINE}} - Ae reporting form or system
{{AE_REPORTING_FORM_OR_SYSTEM}}
Show all 17 fields
- Product complaint route
{{PRODUCT_COMPLAINT_ROUTE}} - National reporting scheme
{{NATIONAL_REPORTING_SCHEME}} - Local clinician reporting policy
{{LOCAL_CLINICIAN_REPORTING_POLICY}} - Who in safety reviews contracts with partners and vendors
{{SDEA_CHECK_PROCESS}} - Social media ae procedure
{{SOCIAL_MEDIA_AE_PROCEDURE}} - Personal social media policy
{{PERSONAL_SOCIAL_MEDIA_POLICY}} - LMS or record system
{{LMS_OR_RECORD_SYSTEM}} - Survey URL
{{SURVEY_URL}} - Live session URL
{{LIVE_SESSION_URL}} - Course URL
{{COURSE_URL}} - Educator contact
{{EDUCATOR_CONTACT}}
FAQ
Common questions
Can I run pharmacovigilance and adverse event reporting training online?
Yes. The course is self-paced and online, and the live deck lets you add a live session in the room or online.
How often is this training needed?
At induction + annual refresher (organisation policy); regulators expect staff who may receive safety information to be trained to pass it to the safety department, but set no fixed interval.
Who needs this training?
All staff of pharmaceutical, biotech and distributor companies (sales, medical, marketing, customer service, patient-support, market-research and office staff), plus pharmacists and clinicians who pass safety information to a company.
What records should I keep?
Record completion in your own LMS or record system, so you can show who finished the course and when.
Can I edit the content?
Yes, everything. Change the wording, swap scenarios for ones from your workplace, add your logo, or remove parts that don't apply.
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Ready to run it?
Open the live deck to see how the session runs alongside the course and both surveys.