Introduction
In this blog, we help beginners understand the fundamentals of data entry and coding in pharmacovigilance. We’ll guide you through the key considerations of data entry in processing Individual Case Safety Reports (ICSR).
ICSR case processing is often outsourced and requires substantial resources within the pharmacovigilance team. It serves as a common starting point for individuals entering the field of pharmacovigilance. It encompasses a range of diverse activities, rather than being limited to a single task.
✍️ Notification: While perusing this blog, we also provide a complimentary checklist to enhance your ICSR case processing. Feel free to access it while navigating through the content.
Table of Contents:
- What is Data-Entry?
- Data-Entry in pharmacovigilance
- Duties of a End-to-End case processor in data entry
- Conclusion
- FAQ
What is Data-Entry?
Data entry is the straightforward process of manually inputting or transcribing data from various sources into a database system.
This task involves converting information from physical documents, such as paper forms or handwritten records, into digital format. Data entry typically requires a high level of accuracy and attention to detail.
Check it out, If you’re interested in exploring the entire workflow of ICSR case processing.
“Data entry is the silent architect of organized information, where every keystroke builds the foundation for insightful understanding.”
Data-Entry in pharmacovigilance
In the context of pharmacovigilance, data entry takes on added complexity, as it involves assessments and the critical responsibility of managing data related to public safety.
In pharmacovigilance, data entry tasks primarily fall under the responsibility of the case processing team.
As you are a beginner and wish to pursue a career, this role often serves as the entry point for those aspiring to enter the field of pharmacovigilance.
Data entry in pharmacovigilance essentially entails case processing, a function that has undergone substantial evolution in recent years due to advancements in technology.
Key considerations:
Data entry is far more than just copying and pasting in the field. Dive deeper by understanding the essential aspects such as data validation, accuracy, contextual comprehension, and adherence to guidelines.
Mastering these fundamentals is key to your responsibilities at this level in the world of pharmacovigilance.
Duties of a End-to-End case processor in data entry:
1. Validate Data:
Ensure that the receipt dates and book-in to database match those from the source of the latest information.
2. Entering the data:
Ensure all data fields are filled out accurately and no crucial medical information is overlooked from the source.
3. Coding Skills from various dictionaries:
Invest in improving your proficiency in coding using the MedDRA terminology.
4. Data Coding Accuracy:
Verify that existing information is accurately coded based on the latest information received.
5. Narrative writing:
Ensure the narrative adheres to your company’s conventions.
6. Access Reference Materials:
Check and use the relevant information, such as SOPs (Standard Operating Procedures), documents about the product, and references in emails.
7. Action Items:
Checking and Reviewing action items and make necessary corrections, if there are any pending action to perform.
8. Workflow Routing:
Your responsibility as a case processor ends once you route the case to the next workflow.
✍️ Note: You might wonder why I didn’t include quality review and medical review in the aforementioned points. Yes, you are correct. I did not consider them as part of data entry within pharmacovigilance.
Download our freebie
Version: 1.0
For beginners seeking to enhance their processes with high-quality standards, feel free to download our ICSR Quality Checklist. It’s designed to support your journey and elevate your approach. Get your copy now!
Final note
Errors can be a common occur in all the aspects likewise various fields, but we can minimize them by employing effective techniques and best practices. Leveraging technology allows us to provide value by doing things in a better way.
Is anything absent from the list provided?
Most companies follow these common practices, and this blog gives you a basic understanding of what happens in pharmacovigilance. If you’re new to this, it’s designed to help you learn more about the field.
FAQ:
What is Data Entry mean?
What is Data Entry in Pharmacovigilance?
What are the duties of a data entry associate in pharmacovigilance?
2. Entering the validated data
3. Coding of terms from several dictionaries
4. Narrative writing
5. Workflow routing
6. Self-Quality check
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