Are Your Safety Reviewers Overwhelmed with Basic Data Entry?

In the world of pharmacovigilance, medical device vigilance, and patient safety, one truth is clear — your safety reviewers are some of your most valuable assets. They bring medical expertise, analytical thinking, and judgment to assess the significance of adverse events and ensure compliance with global regulatory requirements. Yet, in many organizations today, these highly trained professionals spend an alarming portion of their time performing repetitive, manual data entry.

Instead of focusing on medical evaluation and signal detection, reviewers are buried under administrative work — coding, formatting narratives, checking missing fields, or aligning MedDRA and WHO-DD terms. The result? Slower case processing, higher error rates, reviewer burnout, and delayed safety insights.

This blog dives into why this problem persists, its hidden costs, and how Tesserblu’s intelligent automation solutions can transform your safety operations by letting reviewers do what they do best — focus on safety, not spreadsheets.

The Hidden Reality: Reviewers Drowning in Manual Work

Pharmacovigilance (PV) teams are often under immense pressure to meet global regulatory reporting timelines — 7 days for serious and 15 days for non-serious cases, per regulations like EMA GVP or FDA 21 CFR Part 314. Yet, a significant amount of reviewer time is spent not on analysis, but on data transcription and validation tasks.

1. Manual Case Intake

Every Individual Case Safety Report (ICSR) starts as unstructured information — emails, PDFs, scanned CIOMS forms, call center notes, or literature articles. Reviewers or data entry staff must manually extract and enter the same information into the safety database (like Argus, ARISg, or SafetyEasy).

It’s not unusual for a reviewer to spend 20–30 minutes per case just ensuring all fields are completed before even starting the medical review. Multiply that by hundreds or thousands of cases monthly, and you can see the scale of inefficiency.

2. Endless Data Verification Loops

After entry, data often needs to be checked, rechecked, and aligned. Common examples include:

• Mapping verbatim adverse event terms to MedDRA preferred terms

• Verifying suspect drug details with WHO-DD dictionaries

• Ensuring seriousness criteria, causality, and expectedness are consistent with the source document

• Updating follow-up information and reconciling duplicates

Each step, though critical, is mechanical and error-prone when done manually.

3. Narrative Writing and Formatting Hassles

Even writing narratives — a crucial part of the ICSR that explains the case chronology — is often a semi-manual process. Reviewers copy-paste from different sections of the source document or database and then reformat everything to meet regulatory or client-specific templates.

This repetitive task consumes valuable time that could otherwise be spent analyzing patterns, identifying emerging risks, or performing quality checks.

4. The Burnout Cycle

When safety reviewers feel more like data clerks than scientists, morale drops quickly. Many PV professionals report burnout from repetitive work and constant time pressure. Instead of focusing on improving signal detection or contributing to aggregate reports, they’re trapped in low-value tasks that offer little intellectual stimulation.

This imbalance not only reduces team satisfaction but also increases turnover — a serious concern in an industry already facing talent shortages.

The Ripple Effect: Why Basic Data Entry Bottlenecks Hurt the Entire Organization

The impact of inefficient data handling in safety operations goes far beyond individual frustration.

1. Slower Case Processing and Compliance Risks

Manual entry creates delays. Each minute spent typing or validating data adds up across thousands of cases. Missing submission deadlines can result in regulatory non-compliance, penalties, and damage to reputation.

2. Increased Error Rates

Even the most diligent reviewers are human. Typographical mistakes, skipped fields, or incorrect term mappings are inevitable in manual systems. These errors compromise data integrity — the foundation of safety analytics and signal management.

3. Escalating Operational Costs

The more cases you process manually, the more full-time equivalents (FTEs) you need. Hiring, training, and retaining these staff adds significant cost, especially when case volumes fluctuate. Automation, by contrast, offers scalable capacity at a lower operational expense.

4. Delayed Insights and Decision-Making

If reviewers are bogged down with entry tasks, signal detection and risk assessment take a backseat. Delayed analysis means slower detection of potential safety issues — which can impact patient outcomes and regulatory trust.

The Core Question: Should Safety Reviewers Be Doing Data Entry?

Absolutely not. Your reviewers are medical and scientific experts trained to make critical safety judgments. Their time is best spent on:

• Causality assessment

• Signal evaluation

• Quality review of complex cases

• Aggregate report input

• Strategic oversight of safety data

Basic data handling tasks — like case intake, coding, field population, or narrative generation — can and should be automated. The key is adopting the right technology to do so efficiently, accurately, and compliantly.

How Tesserblu Can Help: Empower Reviewers, Eliminate Data Overload

Tesserblu is redefining how safety teams manage their workload through AI-driven automation, intelligent data processing, and seamless integration with leading safety databases. Here’s how Tesserblu helps eliminate manual entry fatigue and restore focus to scientific review.

1. Intelligent Case Intake and Data Extraction

Tesserblu’s AI engine automatically extracts key safety data elements from diverse sources — PDFs, scanned CIOMS forms, emails, or call center transcripts — with high accuracy.

Using natural language processing (NLP) and machine learning models trained on pharmacovigilance datasets, the system identifies and populates fields such as:

• Reporter details

• Patient demographics

• Suspect and concomitant drugs

• Adverse event terms

• Seriousness and outcomes

This eliminates the need for manual transcription, drastically reducing turnaround time from hours to minutes per case.

2. Automated Coding and Validation

Manual MedDRA and WHO-DD coding is one of the most tedious steps for safety reviewers. Tesserblu automates this with precision.Its coding module automatically:

• Maps verbatim terms to preferred terms

• Suggests alternatives when ambiguity exists

• Validates entries against current dictionary versions

Reviewers simply review and confirm — instead of spending time searching and typing. This not only boosts accuracy but also ensures regulatory alignment with the latest coding standards.

3. Auto-Generated Narratives

Narratives often take up a disproportionate amount of reviewer time. Tesserblu’s auto-narrative generation feature uses AI to craft medically coherent case summaries based on the structured data.

Each narrative is:

• Grammatically correct

• Chronologically structured

• Customizable to match company-specific templates

Reviewers can still edit or refine the narrative for clinical nuance — but the foundation is ready instantly, saving significant effort per case.

4. Automated Case Quality Checks

Before submission, every case must undergo multiple validation steps — completeness, consistency, and accuracy checks.Tesserblu automates this process through built-in rule-based and AI-driven validation layers that:

• Flag missing mandatory fields

• Detect data inconsistencies between sections

• Validate dates, seriousness, and causality logic

• Alert reviewers of potential duplicates

This ensures each case is submission-ready, reducing rework and rejections.

5. Seamless Integration with Safety Databases

Tesserblu integrates effortlessly with major safety systems — Oracle Argus, ARISg, and Veeva Vault Safety — through secure APIs.This means extracted and validated data flows directly into your existing database without manual copy-pasting.

The result?

• Zero double entry

• Instant data availability

• Consistent reporting formats

It fits into your existing workflows without disrupting regulatory compliance or data security standards.

6. Intelligent Dashboards for Oversight

Beyond automation, Tesserblu provides real-time analytics dashboards so PV leaders can monitor case volumes, processing times, and reviewer workload.Managers gain instant visibility into:

• Bottlenecks in the workflow

• Productivity metrics per reviewer or region

• Timeliness of submissions

This enables data-driven optimization — not guesswork.

7. Compliance and Data Security Built In

Pharmacovigilance data is highly sensitive, often containing patient identifiers and confidential medical information. Tesserblu’s infrastructure is built with end-to-end compliance to global standards including:

• GDPR

• HIPAA

• 21 CFR Part 11

• ISO 27001

Every data transaction is encrypted, auditable, and securely logged — ensuring both patient privacy and regulatory trust.

The Impact: Transforming Safety Operations from Reactive to Strategic

Organizations that adopt Tesserblu report dramatic improvements in operational efficiency and reviewer satisfaction.

Here’s what changes when basic data entry is no longer a bottleneck:

• Case processing times are reduced by up to 60%.

• Reviewers spend more time on medical evaluation and signal detection.

• Compliance audit findings drop due to improved data quality.

• Teams experience lower burnout and higher retention.

• Management gains better insight into safety operations through analytics.

In essence, Tesserblu frees your reviewers from repetitive data chores and empowers them to contribute where their expertise matters most — ensuring patient safety.

A Future Where Reviewers Focus on Safety, Not Screens

The safety landscape is evolving rapidly — increasing case volumes, expanding global markets, and growing regulatory scrutiny. Manual workflows simply cannot scale to meet these demands.

Automation isn’t about replacing reviewers — it’s about augmenting them. It allows your experts to focus on the “why” behind the data, not the “how” of getting it entered.

Tesserblu’s AI-driven automation bridges this gap — transforming safety operations from a manual, compliance-driven process into an intelligent, insight-driven ecosystem.

Final Thoughts

If your safety reviewers are overwhelmed with basic data entry, it’s time to reimagine how your pharmacovigilance system operates. Manual processes were never designed to handle today’s data volume or regulatory complexity.

By partnering with Tesserblu, you can modernize your safety workflows, reduce repetitive workload, and elevate the scientific quality of your safety evaluations. Book a meeting if you are interested to discuss more.