Terminology Coder
Technical · Regulatory Authority · Data Entry
Codes terms using controlled terminologies within a regulatory authority.
Also known as: Medical Coder, Clinical Coder
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
- Maintain coding processes, procedures, and training materials in compliance with global GCP, GVP requirements, and other relevant regulatory requirements.
- Develop a consistent medical coding strategy for worldwide use across the global safety database.
- Develop and maintain coding convention materials.
- 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.
- When necessary, develop and maintain the custom MedDRA queries.
- Generate and review reports to support MedDRA coding.
- Assist with coding efforts associated with various reports.
- Execute auto-batch update of terms when necessary.
- Provide feedback regarding improper coding.
- Ensure that all pre and post MedDRA upgrade tasks are completed.
- Facilitate effective coordination around MedDRA understanding and utilization across relevant departments and provide training on medical coding as required.
- Liaise with and provide technical information, advice, and guidance on PV matters to other regulatory colleagues, pharmaceutical companies, relevant national and international bodies, healthcare professionals and members of the public.
- Support external compliance monitoring with PV obligations.
- Participate at all levels (internally and externally) in the formulation and preparation of regulatory policies, guidelines, legislation, and opinions.
- 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 |
| 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 policy, legislation and guideline developmentRef: Regulation (EC) No 726/2004; Directive 2001/83/EC | 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.
