Senior QA-PV Consultant (PV Auditor)

We are seeking a Senior QAPV Consultant to lead and maintain the Pharmacovigilance Quality Management System (QMS) and manage global customer and regulatory inspections.

This is an excellent opportunity for a seasoned PV Quality professional with strong inspection management experience to support a global pharmaceutical organization in ensuring compliance with EU and international pharmacovigilance regulations.

You will oversee the end-to-end QAPV framework, supervise a QAPV Specialist, and drive continuous improvement of PV quality systems and documentation.

Key Responsibilities

• Lead and manage the Pharmacovigilance Quality System (QMS) in compliance with EU GVP and international PV requirements.
• Supervise and mentor a QAPV Specialist, ensuring effective execution of quality activities.
• Prepare for, host, and follow up on regulatory and customer inspections/audits (approx. 15–18 per year, both EU and non-EU).
• Develop and maintain SOPs, Work Instructions, and quality documentation related to PV activities.
• Manage deviations, CAPAs, and change controls related to pharmacovigilance operations.
• Ensure the ongoing compliance and continuous improvement of PV processes and systems.
• Collaborate cross-functionally with Regulatory Affairs, Quality, and Safety teams to ensure inspection readiness.

Requirements

• Minimum 7 years’ experience in Pharmacovigilance Quality Assurance or PV Compliance within the pharmaceutical or biotech industry.
• Proven experience managing regulatory inspections and customer audits in EU and international markets.
• Strong knowledge of EU GVP, ICH guidelines, and global PV regulatory frameworks.
• Hands-on experience with QMS implementation, SOP management, CAPA handling, and deviation control.
• Excellent communication, leadership, and stakeholder management skills.
• Fluent in English (Italian language skills are an advantage).
• Based in Italy or within the Central European time zone.

Interested? Apply now for immediate consideration or contact Lloyd Broomes – [email protected]

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Business providing Global Staffing services.