Global Pharmacovigilance Quality Audit & Inspection Readiness Coordinator - VIE Contract

Location: Morristown, United States

Target start date: 01/12/2026

Company

hirify.global is an R&D-driven biopharmaceutical company developing medicines and vaccines through immunoscience, AI, data, and digital platforms.

What you will do

• Coordinate audit and regulatory inspection readiness for global pharmacovigilance processes.
• Support preparation, conduct, and follow-up of Global Quality, Business Partner, and Service Provider audits.
• Prepare pre-requests, participate in inspection back rooms, and track findings through closure.
• Manage PV-related CAPAs to ensure timely completion and effective prevention of recurrence.
• Maintain inspection preparedness for PSPV and country PV offices.
• Support external relations with inspectorates, agencies, and pharmaceutical associations.

Requirements

• Experience in pharmacovigilance, medical affairs, regulatory affairs, or quality assurance.
• Experience managing CAPAs and understanding ICH/CIOMS, EU Good Pharmacovigilance Practices, and FDA pharmacovigilance regulations.
• Bachelor’s degree or higher in pharmacy, nursing, biology, health sciences, or a related biological science discipline.
• Fluent English required.
• Strong communication, organization, planning, teamwork, initiative, and cross-functional collaboration skills.
• Proficient use of Excel, PowerPoint, and Power BI.

Culture & Benefits

• International VIE assignment through hirify.global’s iMove program.
• Opportunity to collaborate with diverse science, clinical, digital, and global teams.
• Exposure to AI-powered drug discovery, data, and digital platforms.
• Meaningful work supporting faster and more effective drug development.

Hiring process

• The iMove VIE program is available to European Economic Area citizens aged 18–28.
• Candidates cannot apply for an assignment in their own country of citizenship.
• Applications must be submitted in English.