Global PV Inspection Lead — Readiness & Compliance

AMARIS GROUP SA; Eigenbrakel; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Gym club access

Lunch vouchers

Free language classes

Remote work: 2 days/week

Job summary

AMARIS GROUP SA is seeking a Pharmacovigilance Inspection Management Lead to drive inspection readiness for global PV inspections and ensure compliance with GVP/GCP/GLP. You will collaborate with PV, Regulatory, Clinical, and other functions to review documents and host inspections.

The role emphasizes quality oversight of PV systems, audit readiness, and cross-functional communication. Fluent English is required; French is a plus, with an international, hybrid working environment.

Qualifications

• 5–8 years of experience in pharmacovigilance, GVP quality, or auditing.
• Strong experience in inspection management and hosted inspections is preferred.
• Experience with global regulatory authorities (FDA, EMA, MHRA, etc.) and GVP compliance.

Responsibilities

• Drive inspection readiness activities for global PV inspections.
• Collaborate with PV, Regulatory, Clinical, and other functions.
• Review documentation to ensure compliance with GVP, GCP, GLP.
• Support and host inspections, including front room and back room activities.
• Provide quality oversight on PV systems and processes globally.
• Prepare and support audit/inspection readiness and documentation review.
• Facilitate communication during inspection management.
• Contribute to continuous improvement of inspection management processes.

Skills

Inspection management

Pharmacovigilance

Auditing

GVP compliance

Regulatory knowledge

Stakeholder management

English fluency

French language (plus)

Tools

PV systems

Quality management systems

Vendor management

Job description

AMARIS GROUP SA is seeking a Pharmacovigilance Inspection Management Lead to drive inspection readiness for global PV inspections and ensure compliance with GVP/GCP/GLP. You will collaborate with PV, Regulatory, Clinical, and other functions to review documents and host inspections.

The role emphasizes quality oversight of PV systems, audit readiness, and cross-functional communication. Fluent English is required; French is a plus, with an international, hybrid working environment.