OverviewIn this role you will oversee the Global PV System and alliance governance to ensure regulatory compliance and inspection readiness.
You will support the QPPV and PV governance director, manage PV agreements with external partners, and maintain the PV System Master File.
You will lead global PV training, audits, and regulatory intelligence activities, aligning processes across functions to sustain patient safety and regulatory excellence.
This is a strategic role at a global pharma company focused on continuous improvement and collaboration with cross?functional teams.
You will help shape the PV quality system and strengthen partnerships to support growth and compliance.
Retribuzione / Benefitscompetitive salary
comprehensive benefits
extensive opportunities for professional growth and development
ResponsabilitàCoordinate and maintain global Pharmacovigilance Agreements with external partners
Support updating the Pharmacovigilance System Master File (PSMF)
Plan and oversee global PV training programs and approve local training materials
Participate in internal and external PV audits and assist with inspections
Maintain the Company product list used for PV activities




Manage Global Regulatory Intelligence activities and assess impacts
Ensure timely execution of PV activities per legislation and GVP
Draft and update Global PV SOPs and Working Instructions
Oversee PV archive and ensure inspection readiness
Collaborate across functions to improve PV quality systems and compliance
Requisiti fondamentaliDegree in Pharmacy, Life Sciences, or related scientific discipline
Minimum 3 years in Pharmacovigilance related to GVP Modules I & II, or 2 years in GVP Quality Assurance
Experience in global PV and Quality Systems
Strong knowledge of EU GVP and international PV regulations
Understanding of PV quality systems and governance
Knowledge of ISO **** principles
Experience in regulatory intelligence and impact assessment
Proficiency in Microsoft Office
Professional working proficiency in English
Excellent communication and stakeholder management
Negotiation skills with external partners
Prioritization and multi-tasking in a dynamic environment
GVP knowledge (Modules I and II)
Pharmacovigilance quality systems and governance
ISO **** quality management principles

📌 Sr. Manager, Global Pv System Management & Alliance (Bologna)
🏢 ALFASIGMA
📍 Bologna