Pharmacovigilance Manager - Contract

Aspen Pharma Australia; St Leonards; On-site; AUD 120,000 - 180,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Pharmacovigilance

Leadership

Stakeholder management

Regulatory compliance

Audits & inspections

Project management

ARGUS

MedDRA

Education

Pharmacy degree

Tools

ARGUS

QMS software

Job description

Aspen Pharmacare is one of Australia’s leading pharmaceutical companies, dedicated to improving health and quality of life in the communities we serve through a diverse portfolio of prescription and over-the-counter medicines. Since commencing operations in Australia in 2001, we have grown through strategic acquisitions and long-term partnerships, building a strong presence across Australia and New Zealand as part of our broader Aspen APAC regional organisation.

We are currently seeking a Pharmacovigilance Manager to join our Scientific Affairs team on a 12-month parental leave contract, commencing in November 2026.

Reporting to the Head of Scientific Affairs, the Pharmacovigilance (PV) Manager will act as the Qualified Person for Pharmacovigilance (QPPV) and Pharmacovigilance Contact Person for Aspen Australia and New Zealand. This role leads Aspen's local PV function, ensuring compliance with regulatory requirements and Aspen global standards while partnering across the business on matters impacting patient safety.

Responsibilities will include:

• Acting as QPPV for ANZ and overseeing local pharmacovigilance activities and regulatory compliance.
• Leading and supporting the Pharmacovigilance team to ensure the effective delivery of day-to-day PV operations.
• Maintaining vendor oversight by onboarding and continuously monitoring the performance of external service providers
• Managing Aspen's Pharmacovigilance Quality Management System (QMS), including SOPs, deviations, CAPAs and compliance activities.
• Leading PV audits, inspections and regulatory actions, ensuring ongoing audit readiness.
• Drafting and negotiating Pharmacovigilance agreements with business partners and third-party vendors.
• Leading safety signal management, including routine signal detection and ad-hoc signal validation and assessment
• Overseeing risk minimisation activities, Organised Data Collection Systems (ODCS) and other patient safety initiatives.
• Preparing and overseeing PBRERs, Australian Specific Annexes (ASAs), Risk Management Plans (RMPs) and related pharmacovigilance deliverables.
• Delivering pharmacovigilance training and guidance to internal and external stakeholders and supporting case processing activities as required.
• Reporting PV compliance metrics and KPIs, while partnering with Aspen APAC to support drug safety activities across Asia Pacific markets.

About You

You will be a highly motivated and hands‑on Pharmacovigilance professional with a passion for patient safety and compliance. You will bring leadership capability, excellent stakeholder management skills and a demonstrated ability to influence and collaborate across a broad range of functions. To be successful in this role, you will possess:

• A degree in Pharmacy, Medical Science, Health Sciences or a related discipline
• Minimum 5 years' Pharmacovigilance experience, with a strong working knowledge of Australian and New Zealand pharmacovigilance regulations and guidelines, as well as the EMA GVP modules
• Experience leading audits, inspections and compliance activities
• Strong project management, communication and problem-solving skills
• Experience with pharmacovigilance databases such as ARGUS (or similar)
• Knowledge of MedDRA coding and case processing activities, including reconciliation, sampling review, peer review, case assessment, etc.
• A continuous improvement mindset and commitment to patient safety.