Patient Safety Associate, Patient Safety & Risk Management Australia | Hybrid | Full-Time Deliver Excellence in Pharmacovigilance Join Our Patient Safety Team as a Patient Safety Associate and assist in the day‑to‑day delivery of pharmacovigilance and safety related projects, including processing safety information received by, or requiring action on behalf of clients. About the Role In this role, you will: Act as part of PS & RM Team in line with the scope of the project to meet project outcomes and deliverables ensuring compliance. Work within the systems and processes designed to meet Good Pharmacovigilance Practices (GVP). Ensure that all potential adverse events or product complaints associated with adverse events, are appropriately reported and followed up according to client procedures. Evaluate adverse events & follow up reports received from various channels and assess seriousness based on criteria. Process & report safety data as per SOP and client instructions to maintain client and regulatory compliance. Maintain the integrity of client safety data registered into the safety databases. Participate in internal and external audits. Perform literature surveillance and regulatory authority adverse event searches. Assist the Project Manager or the Patient Safety Manager/ Senior Manager as requested (e.g. to provide input to SOPs or Safety Data Exchange Agreements). What You Bring Health Science degree or equivalent. Minimum 3 years of experience in a drug safety or equivalent role in a highly regulated industry e.g., pharmaceutical or devices. Good working knowledge of the regulatory requirements for managing and reporting adverse events in Australia and New Zealand. Experience in clinical trial pharmacovigilance Understanding of the applicable Australia, New Zealand and EU requirements Highly developed service, communication, organisational and problem‑solving skills. High level of attention to detail and computer literacy with experience in safety database (Argus, ARISg, Veeva Safety). Practical experience in SOP writing and document management. Why Join Us? Work with a diverse range of clients across medicines, vaccines, and medical devices, expanding your technical expertise and making a meaningful impact in Patient Safety across multiple therapeutic areas Enjoy a flexible, hybrid work model and commitment to work‑life balance Join a company that values expertise, excellence, collaboration and continuous improvement Ready to make a bigger impact? Click Apply Now and help shape the future of pharmacovigilance across JAPAC . #J-18808-Ljbffr
Patient Safety Associate (Australia)
GROUPE PRODUCTLIFE
city of melbourne, city of melbourne
Published 4 days ago
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