ANZ Pharmacovigilance Manager & QPPV Lead

Health and Aged Care Professionals; Sydney; Presencial; AUD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Health and Aged Care Professionals in Sydney, NSW, is seeking an experienced Pharmacovigilance Manager to lead ANZ PV operations on a 12-month contract. This pivotal role involves directing the local PV team and ensuring compliance with regulatory requirements across Australia and New Zealand.

As QPPV and primary PV contact for the TGA, you will oversee adverse event reporting, safety information processing and ongoing safety improvements, working closely with Medical Affairs, Regulatory Affairs

Formación

• Pharmacovigilance leadership with 5+ years of experience.
• Proven line management experience with coaching and development.
• Strong knowledge of AU/NZ PV requirements.
• Excellent stakeholder management and communication skills.

Responsabilidades

• Lead ANZ Pharmacovigilance operations, ensuring compliance with local requirements.
• Serve as QPPV and primary PV contact for the TGA.
• Oversee adverse event reporting and safety information processing.
• Manage safety issues and corrective/preventive actions.
• Lead, coach and develop the PV team.
• Maintain audit readiness and oversee CAPAs.
• Partner with global teams and external stakeholders to strengthen PV practices.

Conocimientos

PV leadership

QPPV responsibilities

Stakeholder management

Regulatory knowledge

People development

Educación

Pharmacy degree

Descripción del empleo

Health and Aged Care Professionals in Sydney, NSW, is seeking an experienced Pharmacovigilance Manager to lead ANZ PV operations on a 12-month contract. This pivotal role involves directing the local PV team and ensuring compliance with regulatory requirements across Australia and New Zealand.

As QPPV and primary PV contact for the TGA, you will oversee adverse event reporting, safety information processing and ongoing safety improvements, working closely with Medical Affairs, Regulatory Affairs