At a Glance
- Tasks: Lead pharmacovigilance activities and ensure compliance with regulations for patient safety.
- Company: Aspen Pharmacare, a top pharmaceutical company in Australia focused on health improvement.
- Benefits: Competitive salary, professional development, and a chance to make a real impact.
- Other info: Dynamic role with opportunities for growth and collaboration across the Asia Pacific region.
- Why this job: Join a passionate team dedicated to patient safety and regulatory excellence.
- Qualifications: Degree in Pharmacy or related field and 5 years of pharmacovigilance experience required.
The predicted salary is between 82800 - 101200 $ per year.
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 Med DRA coding and case processing activities, including reconciliation, sampling review, peer review, case assessment, etc.
- A continuous improvement mindset and commitment to patient safety.
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Pharmacovigilance Manager in St Leonards employer: Aspen Pharma Australia
Aspen Australia is an exceptional employer, offering a dynamic work environment where innovation and collaboration thrive. With a strong commitment to employee growth, we provide ongoing training and development opportunities, ensuring our team members can advance their careers while making a meaningful impact in the healthcare sector. Located in the vibrant Melbourne North and Ballarat region, employees enjoy a supportive culture that values work-life balance and community engagement.
