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TechnicalT.I.QA.AUD
PV Auditor
Technical · Industry · Quality Assurance
Plans and conducts pharmacovigilance audits.
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 management and conduct of internal audits of the PV system and partners with PV responsibilities.
- Develop and maintain the PV audit strategy.
- Develop the annual audit schedule for PV audits based on annual risk assessments and PV audit strategy plan.
- Lead, plan, conduct PV audits, and report out of both routine and for-cause/ad hoc PV audits in accordance with the approved schedule.
- Deliver PV audit reports and review and/or approve proposed CAPA plans in accordance with internal timelines.
- Maintain responsibility for and oversight of audits conducted by PV contractors, when applicable. This includes identifying suitable PV audit consultants, working with Procurement to establish contracts and providing relevant training in accordance with company procedures.
- Participate in PV inspections in core and supporting roles, assist with the preparation and delivery of appropriate training materials, advise and contribute to interview coaching.
- Contribute to quality standards of internal cross-functional processes.
- Interpret and apply PV-related regulations/policies to processes and decisions made when required; provide cross-training to other team members in matters of PV, when appropriate.
- Cooperate with the audited functions and provide advice and support where required in the execution of remediation actions (CAPAs) to ensure compliance with regulatory and quality expectations and requirements.
- Approve CAPAs and regularly review progress and provide ongoing support in all PV compliance matters.
- Contribute to the QA team by conducting peer-review of audit reports conducted by other team members.
- Contribute to the continuous improvement and maintenance of the QA and QMS by writing relevant SOPs and guidance documents.
- Provide expertise to enhance audit tools and templates in PV and update PV report templates, checklists, and other documents as required.
- Act as subject matter expert to provide expertise and knowledge to less experienced auditors, business partners and company entities on quality and compliance processes/procedures.
- Maintain and enhance quality audit standards and procedures for the harmonized audit process.
- Complete all training requirements in a timely manner.
- Responsible for ongoing maintenance of personal training records to ensure audit and inspection readiness at all times.
- 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 Auditor 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 |
| 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.
