Global R&D QA, Senior PV Auditor

TL;DR

Global R&D QA, Senior PV Auditor (Pharmacovigilance): Verify quality systems and ensure compliance in pharmacovigilance at global and affiliate levels with an accent on PV audits, SOP harmonization, and continuous improvement. Focus on managing risk-based audits, developing global audit strategies, monitoring CAPA implementation, and providing expert QA inputs to PV projects.

Location: Italy, with possibility of smart working

Company

International research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, headquartered in Parma, Italy.

What you will do

• Manage PV audits to hirify.global PV system, affiliates, business partners, service providers, and PASS studies, including risk-based planning, conduction, and CAPA monitoring.
• Contribute to global PV audit strategy development and annual planning.
• Cooperate in selecting and managing PV QA service providers.
• Review and write PV SOPs/WIs for audits and ensure PSMF quality review.
• Plan and execute PV audit trainings for global and affiliate personnel.
• Act as QA PV partner for projects, manage quality metrics, and engage with QPPV and stakeholders.

Requirements

• At least 5+ years as Pharmacovigilance Auditor in pharma companies or as consultant on international projects, or equivalent in Global PV System management/QMS compliance.
• Scientific Master’s degree.
• Fluent English.
• Knowledge of GVP Modules, ICH and ISO principles, PV Quality Management Systems, pharmacovigilance processes, auditing and training techniques.

Culture & Benefits

• Comprehensive healthcare programs, work-life balance initiatives, and robust relocation support.
• Competitive salary with performance bonuses benchmarked to market.
• Flexible working arrangements, remote work options, and tax assistance for foreign colleagues.
• Access to resources and training for development in a dynamic environment.
• Commitment to diversity, inclusion, sustainability as a Benefit Corporation and B Corp.