Pharmacovigilance Specialist
Location: Macquarie Park, NSW, Australia
Contract: 1‐Year Fixed‐Term, full‐time with competitive remuneration and benefits.
Responsibilities
* Execute local pharmacovigilance processes and collaborate with internal teams and external partners.
* Manage the AE case lifecycle: intake, acknowledgement, tracking, translation to English where applicable, follow‐up, and reporting of PQCs in line with PV procedures, local regulations and Corporate Policy 01 Patient Safety.
* Perform literature screening and Health Authority monitoring; coordinate related submissions (PSURs, RMPs, aggregate reports).
* Support PV audits, inspections and vendor audits; assist with readiness activities and develop CAPAs in response to findings.
* Review and support the negotiation of local PV agreements; conduct local qualification/due diligence and maintain business partner compliance records.
* Maintain and update PV controlled documents and training materials; support onboarding and deliver local training as instructed.
* Support PV self‐inspections and compliance corrective actions for late reports; oversee implementation of Risk Minimisation Measures.
* Complete required trainings by due dates prior to performing associated activities.
* File, store and archive safety and regulatory documentation per departmental, company and local requirements.
* Perform independent QC of selected PV activities and undertake other tasks as requested by the Manager.
Qualifications
* Health, life science, or medical science degree, or equivalent by education/experience.
* Pharmaceutical industry experience is preferred.
* General knowledge of AE reporting and PV regulations is preferred, not essential.
* Fluency in English (written and spoken); proficiency in the local language.
* Strong communication, organisational and time‐management skills.
* Ability to work collaboratively across functions and independently with minimal supervision.
* Demonstrated ability to drive process improvements that enhance quality or add business value.
What You Can Expect
* Work autonomously with strong support and mentorship within a trusted global pharmaceutical organisation.
* Opportunity to upskill and develop your expertise through targeted training during the contract.
* Flexible working arrangements and exposure to new skills and responsibilities.
* A collaborative team culture with like‐minded colleagues and meaningful cross‐functional exposure.
Equal Opportunity Statement
We are an equal opportunity employer, committed to fostering an inclusive workplace.
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