Pharmacovigilance Associate

Job Title: Pharmacovigilance Officer

Location: Melbourne, Australia (Hybrid: 1-2 days in office)
Employment Type: Full-time (1 FTE), permanent

We are seeking a detail-oriented and experienced Pharmacovigilance (PV) Officer to support the safety surveillance of clinical and post-marketing products. This role is integral in maintaining regulatory compliance and upholding patient safety standards.

You will be part of a global and innovative pharmaceutical company committed to advancing medical science and will attend the office in Melbourne 1-2 days per week to collaborate with the team. This organization prides itself on being a leading independent pharmaceutical group, dedicated to addressing unmet medical needs. With a strong focus on research and development, it aims to improve patient outcomes and contribute to reducing the social and economic impact of disease worldwide.

What you will be doing:

• Perform end-to-end case processing of Individual Case Safety Reports (ICSRs), including:

  • Triage

  • Data entry

  • Peer review / QC

  • Case follow-up

  • Finalisation

• Conduct reconciliation activities with Competent Authority(ies), ensuring alignment between internal records and external reporting systems.

• Participate in PV vendor and service provider oversight, including supporting the establishment, review, and maintenance of Pharmacovigilance Agreements (PVAs) with business partners and external vendors.

• Support the preparation of periodic and ad hoc safety reports (e.g. PSURs, DSURs).

• Maintain timely and accurate data entry in safety databases (e.g. Argus, ARISg) in accordance with global regulatory timelines.

• Collaborate closely with cross-functional teams including Regulatory Affairs, Clinical, and Quality to ensure compliance with local and global safety reporting obligations.

• Contribute to audits, inspections, and continuous process improvement initiatives.

You are:

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field.

• 1–3 years of direct experience in a PV or drug safety role within a pharmaceutical, biotech, or CRO environment.

• Solid knowledge of international PV regulations and guidelines (e.g. EMA, FDA, TGA, ICH-GCP).

• Proven experience in end-to-end case processing, including triage, data entry, QC, follow-up, and finalisation.

• Demonstrated involvement in reconciliation activities with Competent Authority(ies).

• Hands-on experience managing or working with service providers, with a clear understanding of PV Agreements involving business partners and/or vendors.

• Strong attention to detail, problem-solving mindset, and excellent communication skills.

• Experience working in a matrix environment and managing competing priorities.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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