Build training around the work people perform
An effective programme helps people carry out their responsibilities with greater confidence and consistency. The content should reflect actual tasks, decisions and escalation routes.
Qinecsa’s Pharmacovigilance Training is designed around organisational needs and practical application.
Step 1: Identify the audiences
List the roles that need pharmacovigilance knowledge and the activities they perform. Separate specialist learning needs from general awareness needs.
Consider new starters, experienced staff, managers and relevant partner teams. People with different responsibilities may need different levels of detail, even when the subject is the same.
Step 2: Assess training needs
Review role descriptions, process changes, questions raised by staff and evidence from operational performance. Use discussions or proportionate assessments to identify areas requiring support.
Findings from Pharmacovigilance Benchmarking may help identify wider capability gaps. However, first check whether an apparent training issue is actually caused by unclear procedures or inadequate resources.
Step 3: Define learning objectives
Describe what a learner should be able to do after training. Objectives might include recognising information that needs escalation, following a revised workflow or documenting a decision correctly.
For EU pharmacovigilance activities, GVP Module I links personnel training with assigned responsibilities, training records and evaluation of understanding. Use the requirements applicable to your organisation when defining the programme.
Step 4: Select content and delivery methods
Choose methods that suit the learning objective, audience and working environment. Workshops can support discussion and judgement, while structured learning materials can help communicate consistent foundational information.
Build examples around relevant processes and realistic decisions. Avoid including confidential information in training scenarios unless its use is appropriately controlled.
Step 5: Evaluate practical understanding
Use questions, scenarios or observed activities to check whether learning has been understood and can be applied.
A person may recall a definition but still be uncertain about what to do in practice. Design assessments around the decisions or tasks that matter for the role.
Step 6: Maintain and update the programme
Record assigned training, completion and assessment outcomes. Identify who owns each module and when its content should be reviewed.
Updates identified through Regulatory Intelligence may trigger training changes. Where learning needs arise from wider organisational change, connect the programme with your Pharmacovigilance Consulting priorities.
Frequently Asked Questions: Creating a Pharmacovigilance training programme
Map roles against activities and potential contact with safety information. Determine what each group needs to recognise, perform or escalate. Include relevant functions outside the specialist safety team where their work affects pharmacovigilance processes.
They may share some foundational content, but their learning needs will differ. Experienced staff may benefit from advanced scenarios, updates or focused development. Use an assessment of responsibilities and current capability to determine the appropriate level.
Describe an observable action, such as correctly applying an escalation route or completing a process step. Avoid vague objectives such as “understand pharmacovigilance”. Clear objectives make it easier to select content and assess learning.
Show which learning modules apply to each role, when they are required and how completion is recorded. Include the module owner and review status where useful. Keep the matrix aligned with current responsibilities and procedures.
Use realistic examples, familiar process steps and decisions employees actually face. Invite questions about difficult situations. Explain where learners can find approved procedures and whom they should contact when an issue falls outside the example.
Consider the objective and the level of interaction needed. Online learning can support consistent delivery of structured content. Workshops can be useful for complex decisions, discussion and practical exercises. A combination may suit mixed learning needs.
Use short scenarios, demonstrations, case discussions or supervised tasks. Ask learners to explain their reasoning and the actions they would take. Choose an assessment proportionate to the responsibility and the consequences of an error.
Identify the specific knowledge or skill gap and provide targeted support. Reassess using an appropriate method. Consider whether the problem also reflects unclear training materials, an unsuitable delivery approach or a process that needs clarification.
Review it when responsibilities, procedures, systems or relevant requirements change, and according to your planned review arrangements. Feedback, errors and recurring questions can also indicate that content needs revision.
Compare relevant evidence before and after training, allowing time for learning to be applied. Look at task quality, repeat errors, escalation decisions and supervisor feedback. Consider other changes that may also have influenced the results.
Develop a programme that fits your team
Explore Qinecsa’s Pharmacovigilance Training services to discuss learning needs, practical delivery and ways to evaluate understanding.