QPPV & PV Lead – ANZ (12-Month Contract)

Aspen Pharma Australia; St Leonards; Sur place; AUD 120 000 - 180 000; Plein temps

Résumé du poste

Aspen Pharmacare Australia is seeking a Pharmacovigilance Manager to lead the local PV function as QPPV and PV Contact Person for Australia and New Zealand on a 12-month parental leave contract, commencing November 2026.

Reporting to the Head of Scientific Affairs, you will oversee compliance with regulatory requirements, manage PV audits and QA, coordinate signal management and RMPs, and drive training and stakeholder collaboration across Aspen APAC.

Qualifications

• Degree in Pharmacy, Medical Science, Health Sciences or related discipline.
• Minimum 5 years' Pharmacovigilance experience with AU/NZ regulations and EMA GVP modules.
• Experience leading audits, inspections and compliance activities.
• Strong project management, communication and problem solving skills.

Responsabilités

• Act as QPPV for ANZ and oversee local PV activities and regulatory compliance.
• Lead PV team to ensure day‑to‑day PV operations.
• Maintain vendor oversight of external service providers.
• Manage PV Quality Management System including SOPs, deviations, CAPAs and compliance activities.
• Lead PV audits, inspections and regulatory actions, ensuring audit readiness.
• Draft and negotiate Pharmacovigilance agreements with partners and vendors.
• Lead safety signal management including signal detection and validation.
• Oversee risk minimisation activities and ODCS.
• Prepare PBRERs, ASAs, RMPs and related PV deliverables.
• Deliver PV training and support case processing as required.
• Report PV compliance metrics and support drug safety activities across APAC.

Connaissances

Pharmacovigilance

Leadership

Stakeholder management

Regulatory compliance

Audits & inspections

Project management

ARGUS

MedDRA

Formation

Pharmacy degree

Outils

ARGUS

QMS software

Description du poste

Aspen Pharmacare Australia is seeking a Pharmacovigilance Manager to lead the local PV function as QPPV and PV Contact Person for Australia and New Zealand on a 12-month parental leave contract, commencing November 2026.

Reporting to the Head of Scientific Affairs, you will oversee compliance with regulatory requirements, manage PV audits and QA, coordinate signal management and RMPs, and drive training and stakeholder collaboration across Aspen APAC.