Understand how your safety function operates
A pharmacovigilance operating model describes how people, processes, technology and oversight work together. It includes the relationships between internal teams, affiliates and service providers, as well as the decisions and controls that support delivery.
Pharmacovigilance Management Consulting helps organisations examine these connections and address weaknesses that affect performance.
Step 1: Map the current model
Document the main activities, responsible teams, systems and handoffs. Follow work from its starting point through review, decision-making and completion.
Speak to the people performing the tasks. Written procedures may describe the intended process, while operational discussions reveal how it works under pressure.
Record where teams rely on manual workarounds, informal knowledge or repeated clarification.
Step 2: Identify the causes of recurring problems
Review available performance data alongside examples of delays, errors, escalations and rework. Look for patterns across teams or process stages.
A late output may reflect insufficient capacity, unclear ownership, inconsistent source information or an ineffective handoff. Treating the visible symptom alone may leave the underlying issue unresolved.
Pharmacovigilance Benchmarking can provide additional structure when assessing the maturity and consistency of the wider model.
Step 3: Clarify responsibilities and decision-making
Define who performs each activity, who is accountable, who must be consulted and who needs to be informed. Pay particular attention to decisions involving several functions or external partners.
Confirm escalation routes, approval authority and arrangements for absence or increased workload. Responsibilities should be understood by the people involved and reflected in relevant documentation.
Step 4: Strengthen oversight of partners and handoffs
Review the information exchanged with vendors and affiliates, including its format, timing and acceptance criteria. Agree how exceptions will be reported and resolved.
Performance meetings should lead to decisions and actions. Track recurring issues, identify owners and check whether previous corrective actions have worked.
Step 5: Introduce changes in a controlled sequence
Prioritise changes by their potential effect on safety, compliance and operational continuity. Separate urgent measures from improvements that require wider planning.
Where several problems share a common cause, coordinate the response through Pharmacovigilance Consulting. Test significant changes on a manageable scope before extending them, where appropriate.
Step 6: Support adoption and review performance
Explain what is changing and how it affects each role. Update procedures, working instructions and supporting tools together.
Use targeted Pharmacovigilance Training to help teams apply revised processes. Review performance after implementation and adjust the model where evidence shows that further improvement is needed.
Frequently Asked Questions: Improving your pharmacovigilance operating model
Start with one important workflow and map it with the people who perform it. Record the trigger, inputs, decisions, handoffs and outputs. Use this to identify immediate uncertainties before expanding the review to connected activities.
Examine when delays occur and what work is waiting. A genuine capacity issue may persist despite clear processes and balanced workloads. Repeated clarification, rework or unnecessary approvals can indicate process weaknesses that additional staffing alone will not resolve.
Prioritise handoffs associated with missed commitments, incomplete information, repeated queries or unclear acceptance. Interfaces between internal teams and external partners are often useful starting points because responsibilities and expectations may be documented differently.
A RACI matrix records who is responsible, accountable, consulted and informed for a task or decision. It can clarify ownership, but it should be tested against real scenarios. A matrix that nobody understands or uses will have limited value.
Define the situations requiring escalation, the person or role to contact, the expected response and the backup route. Test the process using realistic examples, including absence, urgent decisions and issues involving more than one organisation.
Understand the process and its requirements before selecting or configuring technology. Otherwise, a new system may reproduce existing weaknesses. Process design and technology planning can then proceed together with clear requirements and appropriate controls.
Assess the significance of each issue, the likelihood of recurrence and the effort needed to address it. Deal with urgent risks first, then sequence other changes around dependencies and available capacity. Record why lower-priority work has been deferred.
Yes, where the activity and applicable controls allow it. Use a defined pilot with agreed participants, success criteria and escalation arrangements. Evaluate the results before extending the approach, and manage any temporary process differences explicitly.
Use measures linked to the original problems, such as reduced rework, fewer overdue actions or more reliable handoffs. Combine quantitative results with evidence that responsibilities are understood and decisions are being made at the appropriate level.
Make revised processes accessible, reinforce them through management oversight and review early exceptions. Ask staff where the new approach is difficult to follow. Persistent workarounds may indicate that the process needs further adjustment.
Build a more effective pharmacovigilance operating model
Qinecsa’s Pharmacovigilance Management Consulting supports improvements to governance, workflows and oversight, helping your organisation translate priorities into practical operational change.