Pharmacovigilance Auditing Unit Head

TL;DR

Pharmacovigilance Auditing Unit Head: Managing global PV audit strategies and quality systems to ensure compliance with international regulatory requirements. Focus on risk-based audit planning, CAPA monitoring, and harmonizing PV processes across global headquarters and affiliates.

Location: Must be based in Italy (Parma), with hybrid/smart working options available.

Company

hirify.global is an international research-focused biopharmaceutical group and certified B Corp dedicated to developing innovative drugs and promoting a healthier world.

What you will do

• Manage PV audits for global systems, affiliates, business partners, and service providers.
• Develop and execute long-term and annual global PV audit strategies.
• Review and harmonize PV SOPs to ensure compliance with current regulations.
• Monitor CAPA implementation and effectiveness across the organization.
• Provide expert QA PV input for global patient safety projects and cross-functional stakeholders.
• Cooperate in the maintenance and quality review of the Pharmacovigilance System Master File (PSMF).

Requirements

• 5+ years of experience as a Pharmacovigilance Auditor or in Global PV System management.
• Scientific Master’s degree.
• Fluent English proficiency.
• Deep knowledge of GVP Modules, ICH, and ISO principles.
• Expertise in PV Quality Management Systems and auditing techniques.
• Ability to work from the Parma office in Italy.

Culture & Benefits

• Dynamic, friendly, and inclusive work environment.
• Comprehensive healthcare programs and work-life balance initiatives.
• Flexible working arrangements and remote work options.
• Robust professional development, training resources, and career growth opportunities.
• Commitment to sustainability and ethical behavior as a Benefit Corporation.