PV Quality Assurance Administrator
Technical · Industry · Quality Assurance
Provides administrative support to PV quality-assurance activities.
Also known as: PV Regulatory Compliance, Clinical QA Associate, Quality Auditor
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
- Ensure that standards are observed for database administration, database design, data capture and data quality control.
- Support quality management activities to ensure compliance with local and international safety requirements and regulatory inspection readiness in collaboration with QA.
- Support the management of the documentation system.
- Support identification of gaps, risks, and opportunities for continuous improvement of the QMS and work on their remediation and implementation respectively.
- Responsible for identifying training needs and supporting development and training conduct.
- 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 PV Quality Assurance Administrator 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 |
|---|---|
| PV quality management system (GVP Module I)Ref: EMA GVP Module I — Pharmacovigilance systems and their quality systems | Expert |
| Audits and regulatory inspectionsRef: EMA GVP Module IV — Pharmacovigilance audits (Rev 1); GVP Module III — Pharmacovigilance inspections | Expert |
| CAPA (corrective and preventive action) managementRef: EMA GVP Module IV — Pharmacovigilance audits (Rev 1) | Intermediate |
| Deviation and non-compliance handlingRef: EMA GVP Module I — Pharmacovigilance systems and their quality systems | 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 |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Quality system |
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| Audit & inspection |
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| Remediation |
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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.
