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TechnicalT.I.DM.DE.PC
Product Coder
Technical · Industry · Data Entry
Codes medicinal products using controlled product dictionaries.
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 coding reported drugs verbatim originated from postmarketing data and clinical development data in individual case safety reports and other PV regulatory documents.
- Validate and classify drug information in controlled vocabulary/adopted drug dictionaries to ensure the completeness, accuracy, and consistency of the reported drug verbatim from postmarketing experience or clinical development data.
- Use internal tools and systems as well as external references to find information about correct trade names and marketing authorisation holder information and identifying substances and ATC assignments.
- Develop and maintain an internal repository of synonyms of medical products and/or actions to be used in mapping drug verbatim or auto-coding or auto-actioned.
- Create and update customized drug groupings either independently or via amending implemented standardized drug groupings, as appropriate.
- Contribute to the development of internal coding conventions of medicinal products, with specific considerations, eg., (prodrugs, chemotherapy regimens, non-unique trade names, umbrella terms, diagnostic agents/non– drug therapies, etc.).
- May participate in decisions relating to the retirement of certain adopted customized drug groupings.
- If applicable, contribute to writing stringent coding guidelines for coding concomitant drugs within PV study protocols, including the development of the prohibited list of medications.
- Flag non-unique trade names to the relevant PV scientist or study team.
- Support internal stakeholders and external business partners with questions relevant to drug/vaccine coded data.
- Cooperate with internal stakeholders and external business partners via providing custom drug queries when requested to support analysis of PV data.
- Might contribute with external stakeholders as a working group member to the development of standardized drug groupings.
- 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 Product 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 |
| ICSR lifecycle: receipt, triage, data entry, quality controlRef: EMA GVP Module VI — Collection, management and submission of reports (Rev 2) | Intermediate |
| 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.
