Head of Quality Assurance PV
Managerial · Industry · Quality Assurance
Enhances the quality culture and is in charge of internal and external audits.
Also known as: Director of Quality Management, Director of Quality Assurance, Director of PV Quality
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
- Enhance Quality culture and promote a Quality mindset into the country governance, working principles and ways of operating.
- Person in charge of internal and external audits.
- Lead and coordinate a network of professionals designated in each country function involved in GxP and health-regulated activities and embark them to address all matters related to Quality, including the support to business and digital initiatives.
- Assure that a process for management of GxP documents and records is in place in all GxP and health regulated areas, considering data integrity principles.
- Organize consistent management of Country Quality documents related to GxP and health regulated activities through an appropriate system.
- Implement a screening process for released global quality documents and local regulations to capture the requirements that must be transcribed into Country Quality documents
- Guide country functions that need to develop or update Country Quality documents and related training modules in their respective domains.
- Ensure that required quality documents are in place, in use and up to date at the country level, providing oversight of GxP areas.
- Manage product complaints received from the market in connection with the concerned Global Quality functions.
- Conduct product complaints’ trend analysis and signal detection, as appropriate.
- Escalate quality events as necessary occurring at the country level according to defined processes and standards and manage subsequent quality and product alerts.
- Lead and coordinate product recall.
- Provide support on Quality matters to the appropriate functions at a country level and according to the defined responsibilities.
- Participate in inspection/audit related readiness activities and provide support for internal and external PV audits.
- Engage in continuous improvement of relevant processes.
- Provide adequate support, motivation, encouragement, and effective management for all relevant staff.
- Develop and implement relevant training.
Overall required level: Expert.Draft competency standard for the Head of Quality Assurance PV role. As a managerial role, expert-level knowledge of the managed function and strong oversight, compliance and people-management competencies are expected. Levels are an initial proposal derived from the role's job description and typical pharmacovigilance practice, pending expert review.
Prerequisites
Mandatory prerequisites
- →University degree in medicine, pharmacy, life sciences or a related discipline
- →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 | Expert |
| The pharmacovigilance system and Pharmacovigilance System Master File (PSMF)Ref: EMA GVP Module II — Pharmacovigilance system master file (Rev 2) | Expert |
| Individual case safety report (ICSR) management and regulatory reporting timelinesRef: EMA GVP Module VI (Rev 2); ICH E2D(R1); ICH E2B(R3) | Expert |
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 |
| Signal management process (GVP Module IX)Ref: EMA GVP Module IX — Signal management (Rev 1) | Expert |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Intermediate |
| Data integrity principles (ALCOA+) | Intermediate |
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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