30 minutes
1 module
NOTE
This is an organisation-wide course and not for individual enrolments. It needs to be customised to reflect organisational products, pharmacovigilance procedures, internal reporting timelines, key contacts, and escalation routes.
Pharmacovigilance is often used alongside the Code of Marketing Practice, POPIA, Anti-Bribery and Corruption, and other healthcare or regulated-industry awareness courses.
overview
Product safety needs fast reporting
Pharmacovigilance is the regulated process through which information about medicines is collected and assessed after registration, so that emerging safety concerns can be identified and managed.
This pharmacovigilance training course prepares employees to recognise information relevant to pharmacovigilance and to report it promptly through the correct internal channels.
In South Africa, the Medicines and Related Substances Act, its regulations, and SAHPRA’s post-marketing requirements place reporting and record-keeping duties on applicants, certificate holders, and certain licence holders. Relevant information may first reach an organisation through a sales call, a medical enquiry, a quality complaint, a patient-support interaction, or an ordinary workplace conversation. Employees therefore need to know what to recognise and where to report it.
The course
Know what to report and when
The course explains what pharmacovigilance is, why it is necessary and how employee reporting contributes to medicine safety.
It covers serious and non-serious adverse events or reactions, special reportable cases, lack of efficacy, quality complaints, unexpected consequences and incorrect product use.
Learners are shown what information a report should contain, how reporting should be done, the internal timelines to follow, and which reporting contacts or channels to use.
Short knowledge checks set in everyday work situations help learners recognise information that belongs in the pharmacovigilance process and decide what to do with it.
Reporting matters
Product safety information only helps when employees know what to do with it.
Regulatory consequence
SAHPRA can inspect and act
SAHPRA not only receives adverse-event reports but can also inspect pharmacovigilance systems, review whether appropriately trained staff and training records are in place, and require corrective action where weaknesses are found.
Safety information and inspection findings may lead to changes to professional or patient information, restrictions on how a product is used, product recalls, or action against the product’s registration.
This course covers the employee-facing part of that system: recognising safety information and escalating it through the right route. It does not train people to conduct inspections or manage recalls; that specialised work remains within your pharmacovigilance function. What the course gives you is employees who are more likely to recognise and pass on what matters, and a training record you can show. Reliable reporting still depends on a route that responds when someone raises something.
Align pharmacovigilance awareness with the reporting process your organisation uses.
Got questions? Start here.
Who should complete pharmacovigilance training?
The course is designed for organisations whose employees and managers may receive, handle, or pass on information about a medicine’s safety, quality, effectiveness, or use.
It may be relevant to sales, medical affairs, customer/patient support, quality, regulatory affairs, operations and other teams whose work brings them into contact with patients, healthcare professionals, customers or product information.
Is this course suitable for beginners or experienced pharmacovigilance professionals?
The course is suitable for beginners and does not assume previous pharmacovigilance knowledge.
Experienced pharmacovigilance, regulatory, medical and quality professionals may also use it as a consistent induction or refresher course for wider employee groups. Their own role-specific professional training will usually go further than this employee-awareness course.
How does this training support SAHPRA reporting requirements?
The course helps relevant employees recognise information that may need to be reported, identify the details to capture, and follow the organisation’s reporting route within the required timeframe.
This matters because the pharmacovigilance team cannot assess and report information that never reaches it. When the course is delivered via a tracked route, the organisation can also retain a record of who was assigned the training and who completed it.
Can this course support pharmacovigilance inspection readiness?
Yes. SAHPRA’s pharmacovigilance inspection guidance considers whether regulated organisations have appropriately trained staff, current training materials, and records of the training provided.
This course can support the employee-awareness and training-record part of that requirement, particularly where it has been customised to reflect the organisation’s reporting procedure and delivered through a tracked training route.
Can pharmacovigilance training be completed online?
Yes. The course is self-paced, takes approximately 30 minutes and can be delivered through Compliance Online’s managed e-learning route called ELLO, or licensed for use through the organisation’s own LMS.
The appropriate route depends on whether the organisation needs the course content only or also needs help managing enrolment, reminders, completion records and reporting.
Can the pharmacovigilance course be customised?
Yes. The course can be customised to include the organisation’s products, pharmacovigilance policy or procedure, internal reporting contacts, timelines, escalation route, terminology and relevant workplace examples.
This helps employees connect the general reporting requirements to the process they are expected to follow when safety information reaches them.
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