Global/HQ QPPV
Leadership · Industry
Implements global PV services and oversees the functioning of PV systems in all relevant aspects.
Also known as: Global Safety Leader
Job description
- Implement global PV services and oversee successful service delivery from an operational perspective.
- Have oversight of the functioning of the PV systems in all relevant aspects, including its quality system.
- Ensure that processes are efficient, high quality, and in compliance with the global legislation.
- Supervise PV systems, including review and revision of documented procedures (e.g. SOP) and identify a need for development or revision of existing documented procedures.
- Where required, take responsibility for, and lead the receipt, processing, reporting, follow-up, and reconciliation of adverse event reports from any source like clinical trials, literature, post-marketing, and pharmaceutical-technical complaints.
- Have awareness of relevant PSMF, RMPs, risk minimisation activities, and periodic aggregate safety reports (e.g., PBRERs, PSURs, DSURs).
- May also manage activities related to clinical trials, e.g., development of Safety Management Plans.
- Implement and evaluate global literature searches.
- Lead client audits and inspections.
- Ensure a suitably organised and managed PV team.
- Support relevant management staff.
- Ensure that information about all relevant suspected adverse reactions are reported to the company and affiliates, as defined in agreements, is collected, collated and is accessible within the PV system.
- Ensure all periodic reports and medical variation applications are planned, tracked and obtained in a timely manner.
- Develop and implement relevant PV training.
- Ensure continuous improvement of resources and materials provided.
- Engage in continuous improvement of the processes.
- Support company governance of business ethic compliance and its implementation.
A QPPV establishes and maintains a pharmacovigilance system, provides Health Authorities with information relevant to product safety and is delegated by the MAH to be personally responsible for the safety of human pharmaceutical products marketed by a company in a given country or region.
Official standard: ISoP Global Competency Standard for Qualified Person in Pharmacovigilance (QPPV), v1.0 — jointly developed by ISoP, the ISoP SIG on PV Professional Qualification Framework and the Institute of Pharmacovigilance (PDF).
Prerequisites
Mandatory prerequisites
- →Mandatory requirements as per applicable regulation
- →Minimum of 5 years of experience in critical areas of PV
- →Minimum undergraduate degree in Life sciences
- →Exposure to competent authority inspection
- →MedDRA Coder certification
- →Proficiency in English, computer literacy
Recommendations
- →Medical degree in human medicine strongly recommended
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
Pharmacovigilance
| Topic | Level |
|---|---|
| Pharmacovigilance aim, scope, and history | Expert |
| PV glossary and definitions | Expert |
| Ethics and leadership in pharmacovigilance | Expert |
| Societal burden of adverse reactions to medicines | Intermediate |
| The global PV-relevant regulatory landscape (including data privacy) | Intermediate |
| Architecture of pharmacovigilance system (industry, regulators, other) | Intermediate |
| Industry-specific knowledge | Expert |
Sciences and Technologies
| Topic | Level |
|---|---|
| Mechanisms underlying adverse reaction to medicines | Basic |
| Information Technology systems applied to pharmacovigilance | Intermediate |
| Collection, processing, and medical evaluation of safety data | Basic |
| Detection and management of safety signals. Benefit vs Risk evaluation | Expert |
| Risk management planning and risk minimisation methods | Expert |
| Safety decision making (including labelling variation) | Expert |
| Pharmacoepidemiology and safety data generation | Basic |
| Generation, distribution, and evaluation of safety regulatory documents | Intermediate |
| Quality Management of PV-Relevant processes (QC, QM, QA, A&I) | Expert |
| Product quality safety management | Expert |
Local regulation
| Topic | Level |
|---|---|
| Local applicable regulations | Intermediate |
Skills
Skills are assessed on their own usage-based four-level scale: N/A — Skill not required; Basic — Passive/delegated usage; Intermediate — Active usage when required, often in collaboration with other specialists; Expert — Active usage on daily basis, usually responsible person, or leader of activities.
Collection and reporting
| Skill | Level |
|---|---|
| Collecting spontaneous adverse drug reaction reports | Basic |
| Collecting reports using active surveillance | Basic |
| Reporting of suspected adverse reaction | Basic |
Analysis and assessment
| Skill | Level |
|---|---|
| Data management in pharmacovigilance | Expert |
| Signal management in pharmacovigilance | Intermediate |
| Interaction between PV and product quality defect systems | Expert |
| Benefit-Risk evaluation of authorized medicinal products | Intermediate |
| Periodic Benefit-Risk Evaluation reporting | Expert |
| Risk management of medicinal products | Intermediate |
Taking measures
| Skill | Level |
|---|---|
| Safety Variations | Expert |
| Safety Communication to competent authorities | Expert |
| Safety Communication to healthcare professionals and patients | Expert |
| Management of post-authorisation pharmacovigilance commitments | Expert |
General skills
| Skill | Level |
|---|---|
| Business continuity of pharmacovigilance systems | Expert |
| Good Documentation Practices | Expert |
| Good Clinical Practices | Expert |
| Data Privacy Protection | Expert |
Attitude
Behavioural competencies expected of this role (not assessed on a level scale).
Cognitive competencies
- →Strategic thinking
- →Analysis and use of information
- →Decision making
Intrapersonal competencies
- →Ethical
- →Independent
- →Professional
- →Performance oriented
Interpersonal competencies
- →Leadership
- →Influencing
- →Communication
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.
