Senior Pharmacovigilance Associate Be the guardian of patient safety across Oceania. In this critical role, based in North Sydney, you'll ensure our life-changing medicines reach patients safely while maintaining the highest standards of pharmacovigilance compliance across Australia, New Zealand, and surrounding territories. Your new role As Senior Pharmacovigilance Associate, you'll play a vital role in safeguarding patients across the Oceania region. Acting as a key point of contact for safety matters, you'll ensure compliance with both local regulatory requirements and Novo Nordisk's global pharmacovigilance standards—work that directly protects the millions of patients who depend on our medicines. Your responsibilities will include: - Acting as back-up Local Safety Responsible Person and Qualified Person responsible for Pharmacovigilance (QPPV) for Oceania, ensuring continuity of critical safety functions - Monitoring and assessing local pharmacovigilance requirements, translating regulatory expectations into practical processes that protect patients - Managing safety case reporting to regulatory authorities including TGA, Medsafe, and other relevant bodies across the region - Overseeing the affiliate safety mailbox and coordinating with Global Patient Safety to action follow-up requests on adverse events, serious adverse events, and pregnancies - Developing and delivering pharmacovigilance training to internal teams and external partners, building capability across the organization - Preparing for and supporting audits and inspections, maintaining the highest standards of documentation and compliance - Collaborating across Sales, Marketing, Medical, Clinical, Regulatory Affairs, and Patient Support teams to embed safety considerations into all activities Your new department Pharmacovigilance sits at the intersection of patient safety, regulatory compliance, and commercial success. You'll be part of the Oceania team responsible for ensuring our expanding portfolio of medicines—from diabetes and obesity treatments to rare disease therapies—meets the rigorous safety standards that patients and regulators expect. Your work will directly enable us to bring innovative treatments to market while maintaining the trust that underpins everything we do. Your skills & qualifications We're looking for someone who combines technical expertise with strong collaboration skills and an unwavering commitment to patient safety. You'll bring: - A degree in biological or chemical sciences, pharmacy, or a medical sciences discipline - Significant pharmacovigilance experience in the pharmaceutical industry, with a solid understanding of safety case processing and regulatory reporting - Knowledge of Australian and New Zealand regulatory requirements (TGA and Medsafe) and international pharmacovigilance standards - Strong attention to detail and documentation skills, with the ability to maintain compliance in a complex regulatory environment - Excellent communication and stakeholder management abilities—you'll work across multiple internal teams and with external partners and regulators - The ability to work independently, prioritize effectively, and maintain composure in a dynamic, fast-paced environment where patient safety is paramount Working at Novo Nordisk Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations. What we offer There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind. Applications are reviewed on an ongoing basis; we encourage you to apply now. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. First Nations people are encouraged to apply. At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Sr Pharmacovigilance Associate (North Sydney, New South Wales, AU) @ novonord

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