Business Process Transformation in Pharmacovigilance

Designing a case workflow, defining user profiles, configuring the product and study library, and establishing submission rules are critical components when envisioning a new future state for business processes. Having had several discussions with different clients, it has become clear that achieving true transformation requires a comprehensive assessment of various aspects beyond just these elements.

Current State, Automations and Overlooked Nuances

To comprehensively assess the current state of safety management processes, it’s essential to examine various aspects including Oversight, Query Management, Follow-up Processes, Inbound and Global Submission Compliance, Local Submissions, Translations, Intake Sources, Peer and Retrospective Quality Review, Governance Charters, Processing Conventions for different case types, RMP Commitments, Reconciliation, and Aggregate Reports, among others.

Modern safety databases offer numerous features that enhance efficiency, but often overlook real-world nuances. Efficiency improvements are only realized when features are aligned with appropriate processes.

To illustrate, let’s consider two examples from the many we at Ultragenic have addressed: i) Follow-up Process and Query Management, and ii) Quality Review and associated Metrics.

(i) Follow-Up Process and Query Management

Current State:

Existing processes typically require strict adherence to guidelines regarding the adequacy of Target Questions, issuance of urgent queries, number of attempts needed, relevant templates to use, and review and issuance of correspondences.

Performing a comprehensive duplicate search to accurately classify inbound cases or responses often involves multiple iterations of hit and match.

Tracking the number of follow-up attempts made can be cumbersome due to varying requirements based on whether the case is spontaneous, related to a clinical trial, a pregnancy case, or if it qualifies for existing Risk Management Plan (RMP) commitments, especially when managed and tracked in Excel sheets.

Impactful Automations:

Modern Safety Databases offer features to alleviate most pain points. Systems can automate the entire questionnaire process by defining a library of questions and triggering rules for their inclusion.

Systems also provide options to issue questionnaires with pre-scheduled reminders in various formats like web links, editable PDFs with controlled list values, or plain emails. They can accurately update, and merge responses received into the respective target fields, significantly reducing follow-up data entry time.

Responses to queries can automatically update the response status in the issued query, create a follow-up case in the Safety Database, and link it to the original case from which the query was issued, thereby reducing triage time.


Responses to queries can often be delivery failure messages or out-of-office replies that lack adverse event (AE) information, mistakenly interpreted by the system as follow-ups.

New information from follow-ups could be “live” (i.e., for cases still in workflow). It’s important to implement controls within the system to facilitate decisions on merging data or parking follow-ups until the current processing cycle is complete.

Not all target questionnaire issuances are electronic; in certain scenarios, the mode could be via traditional mail, especially for cases in a post-market setup. It’s crucial to define a process that accommodates such nuances in the overall solution.

Multiple responses can be received for the same query, especially when queries are issued to a distribution list. Clear protocols need to be established on how such responses are reconciled.

(ii) Quality Review and associated Metrics

Current State:

Typical ICSR quality review processes involve identifying critical, major, and minor data points and assigning weighted scores to these fields based on their classification.

Errors detected in these fields contribute to the overall quality score of the ICSR.

Documentation of these scores is usually maintained in homegrown systems or Excel sheets.

Quality review processes can be inline (during the workflow) or retrospective. Various reports are generated to gain insights into overall quality trends, individual performance, and key performance indicators (KPIs).

Impactful Automations:

Modern databases offer interactive configurable quality control (QC) forms integrated with the workflow. User interfaces are designed to conduct guided reviews by tracking changes to case data automatically and dynamically capturing quality scores, thereby enabling efficient reviews.

Multiple QC forms can be configured for different workflows and assigned based on the case type. This allows different types of QC to be conducted within the workflow, such as peer QC and manager QC. Systems also offer capabilities to devise complex sampling algorithms for selecting cases for quality review.

Performing these activities within the database facilitates easy generation of analytics, providing greater transparency and insights into trends and compliance with conventions.


Quality checks are not limited to data fields alone; there are also checks regarding the adequacy of queries raised for the case.

Scoring practices involve capturing scores at a less granular level (e.g., capturing overall product information rather than scoring individual product attributes). Additionally, errors in dependent fields are not typically scored if errors in the parent field are already captured.

Nuances arise in calculating scores when cases traverse the workflow multiple times and must be considered.

In our extensive experience with PV Automation and Business Transformation projects, we’ve observed that nuances are widespread across pharmacovigilance processes. Ignoring these can hinder the expected ROI from technology implementations. By refining processes to capitalize technological advancements in modern safety databases, we address these complexities effectively. This not only streamlines operations but also drives significant business transformation, enhancing both efficiency and compliance.

These insights highlight the criticality of harmonizing paper-based business processes with system capabilities—an area that the team at Ultragenic focuses on deeply.

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