Global Pharmacovigilance & Alliance Lead

Alfasigma; Bologna; In loco; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Alfasigma is seeking a Senior Manager for Global Pharmacovigilance System Management & Alliance to oversee governance, alignment, and compliance across PV activities. You will work with the QPPV and Global PV Director to maintain critical PV systems and agreements.

You will coordinate PVAs, support PSMF updates, lead PV training, audits, and inspections, and ensure PV documentation meets GVP and ISO 9001 standards across global operations.

Competenze

• Degree in Pharmacy, Life Sciences, or related field.

Mansioni

• Coordinate, review, and maintain global Pharmacovigilance Agreements (PVAs) with partners.
• Support the Global PV Governance Director and QPPV in maintaining the Pharmacovigilance System Master File (PSMF).
• Plan, coordinate, and oversee PV training programs for employees, vendors, and affiliates.
• Review and approve PV training materials to ensure regulatory alignment.
• Participate in internal and external PV audits and inspections.
• Ensure timely updates of the global product list used for PV.
• Oversee Regulatory Intelligence activities including monitoring and impact assessments.
• Collaborate with cross-functional teams to drive PV quality and compliance.

Conoscenze

GVP Knowledge

Stakeholder management

Quality systems

GxP awareness

English proficiency

Formazione

Degree in Pharmacy or Life Sciences

Strumenti

MS Office

Descrizione del lavoro

Alfasigma is seeking a Senior Manager for Global Pharmacovigilance System Management & Alliance to oversee governance, alignment, and compliance across PV activities. You will work with the QPPV and Global PV Director to maintain critical PV systems and agreements.

You will coordinate PVAs, support PSMF updates, lead PV training, audits, and inspections, and ensure PV documentation meets GVP and ISO 9001 standards across global operations.