Global PV Lead, Safety Cluster & Operations

Mundipharma Pty Limited; Sydney; Presencial; AUD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Mundipharma Pty Limited is seeking a Senior Manager, Safety Cluster Lead in Sydney to lead local Pharmacovigilance operations across multiple territories. You will oversee vendors, ensure regulatory compliance, and drive continuous improvement within a globally aligned safety organization.

You will collaborate with Global Safety, QA, Regulatory Affairs, and Clinical Safety teams to ensure high-quality safety operations, inspection readiness, and effective risk management.

Formación

• Strong knowledge of Good Pharmacovigilance Practice (GVP).
• Experience with GVP Module VI reporting.
• Experience managing outsourced PV activities and vendors.
• Exposure to health authority inspections and audits.

Responsabilidades

• Provide operational leadership for local PV activities across designated territories.
• Oversee Pharmacovigilance vendors and service providers.
• Maintain inspection readiness and CAPA program support.
• Collaborate with Global Safety leadership and regional stakeholders.
• Drive global safety process improvements and operational excellence.

Conocimientos

GVP knowledge

Vendor management

Regulatory reporting

Project management

Communication

Stakeholder management

Multi-priority handling

Attention to detail

Educación

Bachelor's degree in Life Sciences/Pharmacy/Medicine/Nursing

Descripción del empleo

Mundipharma Pty Limited is seeking a Senior Manager, Safety Cluster Lead in Sydney to lead local Pharmacovigilance operations across multiple territories. You will oversee vendors, ensure regulatory compliance, and drive continuous improvement within a globally aligned safety organization.

You will collaborate with Global Safety, QA, Regulatory Affairs, and Clinical Safety teams to ensure high-quality safety operations, inspection readiness, and effective risk management.