Qualified Person for Pharmacovigilance (QPPV) with EU GMP Quality System Expertise.
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- QP / RP
- Operations
- EU Importation
- Inspection
- Transtion
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Our culture is driven by excellence and responsibility. We operate with integrity, place our customers at the center of our decisions, and value collaboration, anticipation, and pragmatism. A holistic view allows us to deliver consistent quality and long-term value.
Qualified Person for Pharmacovigilance (QPPV)
with EU GMP Quality System Expertise
with EU GMP Quality System Expertise
We are seeking a highly experienced and proactive Qualified Person for Pharmacovigilance (QPPV) to establish a robust pharmacovigilance framework and ensure ultimate patient safety oversight. In this critical and dual-focused role, you will have a core mission:
- Internal Architect & Responsible Person: Design, implement, and maintain the company's end-to-end Pharmacovigilance System and its underlying Quality Management System (QMS) in strict compliance with EU Good Pharmacovigilance Practices (GVP). You will act as the formally nominated, responsible QPPV for our product portfolio.
- External Consultant & Partner: Provide expert QPPV and pharmacovigilance system consultancy services to our clients. You will assess their PV system maturity, develop compliant frameworks, and directly support them as their named QPPV or in preparing for regulatory inspections, executing missions either remotely or on-site.
This role offers a unique opportunity to build safety systems from the ground up internally while shaping pharmacovigilance excellence for external partners.
Essential Job Functions (Qualified Person for Pharmacovigilance - QPPV):
- Establish, maintain, and oversee the company's Pharmacovigilance System and its core Pharmacovigilance System Master File (PSMF), ensuring it is permanently accessible, accurate, and up-to-date.
- Create and manage the Pharmacovigilance Quality Management System (QMS), including all relevant Standard Operating Procedures (SOPs), in accordance with EU GVP Modules I and II.
- Act as the single point of contact for pharmacovigilance, available 24/7, for all EU Competent Authorities (e.g., FAMHP, EMA) and ensure timely submission of safety reports (e.g., PSURs, SUSARs).
- Oversee all pharmacovigilance activities for both internal and assigned external client portfolios, including signal detection & management, risk management (RMPs), and the management of safety data exchange agreements (SDEAs).
- Ensure the company has adequate resources and processes for the collection, processing, analysis, and reporting of Individual Case Safety Reports (ICSRs) to EudraVigilance.
- Assist in preparing for, hosting, and responding to commitments associated with pharmacovigilance inspections by regulatory authorities. Execute internal & external PV audits as required.
- Maintain oversight of the safety profile of all products and ensure effective risk minimization.
- Maintain Continuous Professional Development (CPD) in conformance with regulatory expectations.
Essential Job Functions (Quality System & Strategic Oversight):
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System Development & Governance:
- Design and implement the end-to-end PV QMS, ensuring integration with existing company quality systems (where applicable).
- Develop and maintain key pharmacovigilance performance indicators (KPIs) and quality metrics to monitor the health and effectiveness of the PV system.
- Establish and chair the Pharmacovigilance governance meetings, providing regular updates to senior management.
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Compliance & Audit:
- Ensure ongoing compliance with EU GVP, relevant chapters of the Good Manufacturing Practice (GMP) guide relating to quality systems, and other global PV regulations as required.
- Manage the audit schedule for the PV system, including vendors and partners. Oversee the CAPA (Corrective and Preventive Action) process for findings.
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External Consultancy & Client Support:
- Assess client pharmacovigilance needs, maturity, and gaps.
- Develop tailored PV system strategies, including PSMF creation and QMS documentation.
- Act as the nominated or supporting QPPV for client products, fulfilling all regulatory responsibilities.
- Prepare clients for pharmacovigilance inspections and provide remediation support.
Experience & Education:
- Bachelor’s or master’s degree in Life Sciences, Pharmacy, or a related field.
- Minimum of 3–5 years of direct regulatory affairs experience within the pharmaceutical industry, with a focus on EU procedures.
- Proven experience in establishing or significantly improving a pharmacovigilance system and QMS. Prior formal QPPV nomination or deputy QPPV experience is a strong advantage.
Technical Skills & Knowledge:
- Expert, applied knowledge of EU Good Pharmacovigilance Practices (GVP) modules, especially I, II, IV, VII, and XVI.
- Demonstrable experience in creating and maintaining a PSMF and PV QMS from inception.
- In-depth understanding of safety database structures, signal management processes, and risk management principles.
- Practical experience with EudraVigilance and electronic reporting requirements.
- Familiarity with the interface between GVP and GMP quality systems is highly advantageous.
- Professional proficiency in English is required. Fluency in Dutch and/or French is highly preferred.
Personal Attributes:
- Expert, applied knowledge of EU Good Pharmacovigilance Practices (GVP) modules, especially I, II, IV, VII, and XVI.
- Demonstrable experience in creating and maintaining a PSMF and PV QMS from inception.
- In-depth understanding of safety database structures, signal management processes, and risk management principles.
- Practical experience with EudraVigilance and electronic reporting requirements.
- Familiarity with the interface between GVP and GMP quality systems is highly advantageous.
- Professional proficiency in English is required. Fluency in Dutch and/or French is highly preferred.
- Proactive, self-motivated, and a collaborative team player.
We provide a dynamic and rewarding career that blends impactful work with personal growth and flexibility:
- A foundational and high-impact role where you will architect the pharmacovigilance system for a growing company and directly influence client safety standards.
- A supportive, expert-driven environment where patient safety is the unequivocal priority.
- Diverse professional growth through a blend of internal system ownership and external consultancy projects with a global client network.
- Access to specialized training and a network of experts to deepen your QPPV and quality system expertise.
- A modern, hybrid work model that offers flexibility to work remotely, from our offices, or on-site with clients based on project needs.
- A competitive salary and a comprehensive benefits package.
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