Sr. Manager, Global PV System Management

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/84xbd1

Job description:

Scope of the Role
The Global Pharmacovigilance System & Alliance Senior Manager plays a critical role in ensuring the effectiveness, compliance, and continuous maintenance of the Company’s Global Pharmacovigilance (PV) System. Acting in close collaboration with the Global PV Governance Director and on behalf of the Qualified Person for Pharmacovigilance (QPPV), this position is responsible for overseeing key pharmacovigilance governance activities, maintaining compliance with global regulatory requirements, and supporting the management of strategic alliances and third-party partnerships.
The role ensures that pharmacovigilance processes, systems, agreements, and documentation remain compliant with applicable global regulations, internal procedures, and industry best practices, contributing to patient safety and regulatory excellence across all Company operations.
Your Role
As Global Pharmacovigilance System & Alliance Senior Manager, you will:
- Coordinate, review, and maintain global Pharmacovigilance Agreements (PVAs) with Contract Service Organizations,



distributors, licensees, and other business partners, including related delegation and termination letters.
- Support the Global PV Governance Director and QPPV in maintaining and continuously updating the Pharmacovigilance System Master File (PSMF).
- Plan, coordinate, and oversee global Pharmacovigilance training programs for employees, field force personnel, vendors, and affiliates.
- Review and approve local PV training materials to ensure consistency with global standards and regulatory requirements.
- Participate in and support internal and external Pharmacovigilance audits.
- Support Pharmacovigilance inspections conducted by Competent Authorities at a global level.
- Ensure the accurate maintenance and updating of the Company product list used for PV activities.
- Manage Global Regulatory Intelligence activities, including regulatory monitoring, gap assessments, and impact evaluations.
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/84xbd1