Could your PV team work smarter with better routing rules?

In an increasingly demanding regulatory environment, pharmacovigilance (PV) teams face constant pressure to process safety information faster, more accurately, and with greater compliance. The volume of safety data continues to grow rapidly, driven by new product launches, post-marketing commitments, patient support programs, digital channels, and expanding global markets. Yet, many PV departments still rely on outdated triage methods, manual decision-making, and rudimentary routing logic that cause unnecessary workload, delays, and compliance risks.

The question many PV leaders must ask today is whether their teams could work smarter, not harder, by transforming one of the most foundational steps in case processing: routing rules.

Structured, intelligent, automated routing is no longer a luxury. It is becoming a necessity for any safety organization striving toward operational excellence and regulatory readiness. In this article, we explore why routing rules matter, how poorly optimized workflows hinder productivity, what smarter routing can achieve, and how modern PV technologies like Tesserblu can help enhance routing efficiency.

Why Routing Rules Matter in Pharmacovigilance

Routing rules determine how incoming safety information is categorized, prioritized, and assigned for further processing. They are the backbone of any PV workflow, acting as the first filter that ensures the right case reaches the right team at the right time.

Effective routing rules directly affect:

Regulatory compliance: Deadlines for expedited reporting are strict. Incorrect routing can delay recognition of a serious, unexpected case that should be expedited within 7 or 15 days.

Operational efficiency: Teams waste time when cases are misrouted, requiring repeated reassignment or clarification. Productivity drops when staff work on tasks outside their expertise.

Quality of case processing: By routing cases to the most qualified personnel or specialized units, companies improve consistency and reduce errors.

Resource utilization: When routing rules are optimized, workloads remain balanced across global teams and vendors, reducing bottlenecks.

Audit preparedness: Regulators increasingly evaluate how cases are triaged and assigned. Documented, validated routing logic shows procedural robustness.

Despite all this, routing remains one of the most overlooked aspects of safety operations. Many organizations update routing rules only when something breaks. Others rely heavily on manual review, which can introduce variability and delays.

Common Challenges With Traditional PV Routing Systems

Even the most experienced PV teams encounter challenges when routing is not well structured or automated. Below are common issues affecting efficiency and compliance.

1. Heavy Reliance on Manual Triage

Many companies still depend on case intake teams or medical reviewers to manually decide where a case should go. This increases the risk of human error, particularly when dealing with multiple products, markets, or reporting pathways. Manual triage is also difficult to scale during peak periods such as new launches or large-scale adverse event campaigns.

2. Inconsistent Application of Rules

When routing relies on human interpretation, rules can be inconsistently applied. One reviewer may classify a case as expedited, while another may not. Inconsistency creates quality gaps that may be flagged during audits and inspections.

3. Lack of Documentation and Transparency

As rules evolve over time, many organizations struggle to maintain proper version control or documentation. This makes it difficult to trace why a case was routed a certain way, who made the decision, and whether it aligns with procedures.

4. Poor Integration With PV Systems

Some safety databases offer limited routing capabilities. When PV teams use multiple systems (intake portals, call centers, literature screening tools), routing logic may exist in siloed formats, leading to mismatches and inefficiencies.

5. Difficulty Managing Global Workflows

Global organizations often manage multiple stakeholders, such as affiliates, vendors, call centers, and centralized hubs. Without clear routing rules, communication delays or misassigned cases can significantly impact compliance.

6. Inability to Adapt to New Regulations

Regulatory requirements shift frequently. If routing rules are not easily configurable, teams struggle to adapt quickly, risking non-compliance.

The cumulative impact of these challenges is substantial. Delays, misclassified cases, repeat work, and quality issues result in higher operational costs and create stress for already stretched PV teams. That is why smarter routing is a high-impact opportunity for modernization.

What Smarter Routing Rules Look Like

Modern PV operations are embracing intelligent, automated routing systems that bring structure, predictability, and speed to case processing. Here is how smarter routing rules transform the workflow.

1. Automated Classification

Incoming cases can be automatically classified based on seriousness, expectedness, report type, region, age of the reporter, product family, and more. Automated classification significantly reduces manual review time.

2. Priority-Based Routing

Cases with tight regulatory deadlines, such as serious unexpected adverse reactions, are automatically escalated to specialized teams or high-priority queues.

3. Workload Balancing

Rules can allocate cases based on availability, capacity, time zone, or specialization. This prevents bottlenecks and maintains steady throughput across the team.

4. Multi-Level Routing

A smart routing system can handle complex logic, sending portions of a case to different teams such as medical review, translation, duplicate check, or QC.

5. Configurable Rules Without IT Dependency

Modern systems offer no-code or low-code rule builders that allow PV leads to update routing logic without waiting for long IT releases.

6. Integration Across Intake Channels

Email, call center logs, E2B files, literature alerts, and other intake streams can be incorporated into the same routing construct, ensuring consistency across the entire PV ecosystem.

7. Complete Audit Trail

Every routing decision is logged, time-stamped, and traceable. This strengthens audit readiness and ensures transparency.

8. Real-Time Monitoring

Dashboards allow safety leaders to see how cases are flowing through the system, where delays occur, and how resources are being utilized.

When implemented effectively, smarter routing rules reduce cycle time, improve case quality, support compliance, and empower teams to focus on higher-value tasks such as narratives, assessments, and signal detection.

Benefits of Better Routing Rules for PV Teams

The impact of improved routing rules is profound across the entire case processing lifecycle.

Faster Processing Times

Automated routing eliminates the delay between intake and assignment, reducing overall case cycle time.

Improved Compliance

Better prioritization ensures expedited cases are processed within deadlines. This protects organizations from regulatory findings and penalties.

Higher Quality and Consistency

Standardized routing reduces variability and ensures that cases reach the right experts, improving quality of medical review and downstream outputs.

Better Resource Optimization

Routing rules help distribute work evenly across internal teams and external partners. This allows leaders to scale efficiently during high-volume periods.

Reduced Operational Costs

Less manual intervention means fewer errors, fewer reassignments, and lower overall labor costs.

More Satisfied Teams

Removing avoidable administrative work frees teams to focus on meaningful scientific tasks. This improves job satisfaction and reduces burnout.

In short, routing rules are one of the quickest, most effective ways to improve PV efficiency without major organizational changes.

How Tesserblu Can Help

Tesserblu is designed to modernize pharmacovigilance operations by optimizing workflows, improving automation, and creating an intelligent, unified, and scalable environment for safety teams. When it comes to routing rules, Tesserblu offers several capabilities that directly address PV pain points.

Intelligent Case Intake

Tesserblu automatically identifies key information from incoming reports, including seriousness, product, reporter type, region, and keywords. This enables highly accurate automated triage.

Advanced Rule Configuration

The platform provides a powerful rules engine that allows safety leaders to build complex routing logic without coding or IT dependency. Rules can be updated quickly to meet new regulatory or operational requirements.

End-to-End Automation

From initial intake to assignment, QC, medical review, and submission preparation, Tesserblu supports automated handoffs that minimize manual steps and reduce errors.

Workload and Skills-Based Assignment

Tesserblu routes cases based not just on compliance deadlines but also on team specialization, capacity, and availability. This ensures that cases land with the right individuals every time.

Global Workflow Support

Whether dealing with affiliates, CROs, or centralized hubs, Tesserblu can route cases across geographic and organizational boundaries with full transparency and auditability.

Real-Time Dashboards

Leaders can monitor routing efficiency, processing times, workload distribution, and bottlenecks. This helps teams adjust resources proactively.

Strong Audit Trails

Every routing decision is captured, logged, and traceable. Tesserblu supports compliance with international regulatory standards and makes inspections smoother.

Seamless Integration

Tesserblu connects with intake forms, email systems, call center tools, safety databases, and reporting systems. This ensures that routing is consistent across all data sources.

By modernizing routing rules and workflow automation, Tesserblu helps PV teams eliminate inefficiencies, reduce costs, improve compliance, and operate as a high-performing safety function.

Conclusion: Smarter Routing is the Future of PV Efficiency

As pharmacovigilance grows more complex, the need for intelligent, automated workflows becomes unavoidable. Routing rules, though often overlooked, play a central role in determining how efficiently safety information moves through an organization. Outdated or manual routing not only slows down case processing but also puts compliance and quality at risk.

The good news is that better routing rules can be implemented without disrupting existing systems. Platforms like Tesserblu provide powerful, flexible tools that help PV teams standardize, automate, and scale their workflows. With smarter routing, safety organizations can improve compliance, reduce manual workload, balance resources effectively, and focus on higher-value scientific tasks. Book a meeting if you are interested to discuss more.