Sr. Manager, Global PV System Management & Alliance
Alfasigma
Overview
In 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 / Benefits- competitive salary
- comprehensive benefits
- extensive opportunities for professional growth and development
- Coordinate 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
- Degree 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 9001 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 9001 quality management principles
Offerta di lavoro pubblicata 1 giorno fa
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