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TechnicalT.I.DM.DE.TC
Terminology Coder
Technical · Industry · Data Entry
Codes adverse-event terms and medical history using controlled terminologies.
Also known as: Medical Coder, Clinical Coder
Draft
This competency standard is a working draft prepared for reviewand is not yet an official GPPC standard. Content is derived from the role’s job description and established pharmacovigilance practice, and is subject to change.
Job description
- Responsible for AE coding using standardized terminology from a medical coding dictionary, such as MedDRA.
- Assist in gathering SAEs reports in a timely manner in the preparation of both internal and external RSI safety reports per internal SOPs.
- Medical code into standard dictionaries and writing of narratives based on information provided both on standard forms and from medical records and other documents of diseases and medications.
- Maintain coding processes, procedures, and training materials in compliance with global GCP and GVP requirements, internal quality standards and quality management system.
- Develop a consistent medical coding strategy for worldwide use across the global safety database.
- Develop and maintain coding convention materials; liaise with relevant company’s staff as well as other divisions in implementing coding standards.
- Review and assess the mapping of terms that are not auto encoded.
- Manage and maintain the MedDRA synonym list.
- Create coding conventions reviews.
- Maintain the Library of Standardised MedDRA Queries.
- Generate and review reports to support MedDRA coding.
- Develop coding conventions required across safety databases and develop coding conventions and associated reports to support oversight and consistency of coding where necessary supporting specific coding strategy.
- Manage medical terminologies in different product documents, including labelling information, package insert, etc.
- Assist with coding efforts associated with various reports.
- Execute auto-batch update of terms when necessary.
- Maintain EOI/Search Strategies and update as needed.
- Manage the communication of key coding synonym list changes to applicable stakeholders.
- Provide feedback regarding improper coding.
- Participate in inspection/audit related readiness activities and provide support for internal and external PV audits.
- Contribute, participate, and support team meetings, including materials preparation, meeting minutes writing, and action item tracking.
Overall required level: Intermediate.Draft competency standard for the Terminology Coder role. As a technical role, expert-level command of the specific systems, tools and processes is expected, with working knowledge of the surrounding regulations. Levels are an initial proposal derived from the role's job description and typical pharmacovigilance practice, pending expert review.
Prerequisites
Mandatory prerequisites
- →Relevant qualification or demonstrable experience in the role's domain
- →Relevant pharmacovigilance experience appropriate to the role
Recommendations
- →Working proficiency in English
- →Familiarity with the applicable GVP modules
Concept of levels
Knowledge for each topic is assessed on a four-level scale.
| Level | Expected knowledge |
|---|---|
| N/A | No knowledge required. |
| Basic | Elementary knowledge of the specific regulation; fundamental understanding of the terms and definitions used, a basic understanding of the concept of the regulation, a general overview of what it covers and where it can be found; passive/delegated usage of the regulation. |
| Intermediate | Very good knowledge of the specific regulation; comprehensive understanding of the terms and definitions and of the concept and context of who/when/where/why/how it applies; active usage of the regulation when required. |
| Expert | Excellent knowledge of the specific regulation; in-depth understanding of the concept and of how and why its sections should be implemented and followed, including outcomes and responsibilities for all relevant stakeholders; active usage of the regulation on a daily basis. |
Knowledge
General Knowledge
| Topic | Level |
|---|---|
| Pharmacovigilance principles and Good Pharmacovigilance Practices (GVP) overviewRef: EMA GVP Module I — Pharmacovigilance systems and their quality systems; EU Reg (EC) 726/2004 & Dir 2001/83/EC | Basic |
| The pharmacovigilance system and Pharmacovigilance System Master File (PSMF)Ref: EMA GVP Module II — Pharmacovigilance system master file (Rev 2) | Intermediate |
| Individual case safety report (ICSR) management and regulatory reporting timelinesRef: EMA GVP Module VI (Rev 2); ICH E2D(R1); ICH E2B(R3) | Intermediate |
Role-Specific Knowledge
Includes topics derived from this role's job description.
| Topic | Level |
|---|---|
| Case receipt, book-in and duplicate detectionRef: EMA GVP Module VI (Rev 2), incl. Addendum I — Duplicate management | Expert |
| MedDRA and WHODrug coding of terms and productsRef: MedDRA (MedDRA MSSO); WHODrug (Uppsala Monitoring Centre) | Intermediate |
| Regulatory and internal case-processing timelinesRef: EMA GVP Module VI (Rev 2); ICH E2D(R1) | Intermediate |
| Data integrity principles (ALCOA+) | Basic |
| Audits and regulatory inspectionsRef: EMA GVP Module IV — Pharmacovigilance audits (Rev 1); GVP Module III — Pharmacovigilance inspections | Intermediate |
| MedDRA and WHODrug coding conventionsRef: MedDRA (MedDRA MSSO); WHODrug (Uppsala Monitoring Centre) | Intermediate |
| Safety database administration and configurationRef: ICH E2B(R3); EMA EudraVigilance | Intermediate |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Basic |
| PV quality management system (GVP Module I)Ref: EMA GVP Module I — Pharmacovigilance systems and their quality systems | Intermediate |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Case book-in |
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| Coding |
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| Compliance |
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Get certified for this role
Certification validates prerequisites via CV screening and assesses knowledge through an online, AI-proctored examination based on the competency standard. The latest terms and requirements for every role and region are maintained by the Institute of Pharmacovigilance.
