Senior Pharmacovigilance Associate

vor 3 Wochen

City of Melbourne, Österreich i-Pharm Consulting Vollzeit

Senior Pharmacovigilance Associate Location: Sydney (Australia & New Zealand coverage) Contract: 6 months (immediate start) Why This Role? Step into a high‑impact position with one of the world’s most respected pharmaceutical organisations. This is your chance to work on cutting‑edge therapies in a dynamic environment where your expertise truly matters. You’ll collaborate with global teams, influence patient safety strategies, and make a tangible difference in healthcare outcomes. What You’ll Do Lead critical PV activities ensuring inspection readiness and compliance with international standards. Author and implement Risk Management Plans (RMPs) , including Australian‑specific annexes and additional risk minimisation measures. Drive collaboration across global safety, regulatory, medical, and commercial teams to deliver seamless PV operations. Oversee patient programs from vendor due diligence and contracting to design input and ongoing oversight. Manage vendor relationships , monitor KPIs, and ensure continuous quality improvement. Support case volume management by prioritising workloads and coordinating across PV associates. Handle safety reporting to TGA and Medsafe, including analysis of global reports for local context. Respond to health authority requests under tight timelines, working with local and global stakeholders. Contribute to authoring SOPs and PV documentation to maintain compliance and operational excellence. Champion team culture , bringing positivity and leadership to a high‑performing, close‑knit team. What We’re Looking For Proven PV experience within a pharmaceutical company in Australia. Strong knowledge of Australian‑specific RMP requirements and regulatory submissions. Hands‑on experience with audits, inspections, and CAPA management. Familiarity with patient programs and vendor oversight. Ability to manage safety reporting and liaise with health authorities. Leadership qualities with a collaborative, positive mindset. Excellent organisational and prioritisation skills. Experience in medical writing or authoring regulatory documents. Exposure to high‑volume case management environments. What’s In It For You? Work on innovative therapies shaping the future of healthcare. Collaborate with global experts in a supportive, family‑like culture. Enjoy a dynamic, fast‑paced environment where your contributions are valued. Competitive contract terms with potential for extension. Interested? Contact Mollie Gunn, Director, to discuss further: #J-18808-Ljbffr

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