Your new role
As Senior Pharmacovigilance Associate, you will safeguard patients across the Oceania region by serving as a key point of contact for safety matters, ensuring compliance with local regulatory requirements and Novo Nordisk's global pharmacovigilance standards.
Responsibilities
* Act as back‐up Local Safety Responsible Person and Qualified Person responsible for Pharmacovigilance (QPPV) for Oceania, ensuring continuity of critical safety functions.
* Monitor and assess local pharmacovigilance requirements, translating regulatory expectations into practical processes that protect patients.
* Manage safety case reporting to regulatory authorities including TGA, Medsafe, and other relevant bodies across the region.
* Oversee the affiliate safety mailbox and coordinate with Global Patient Safety to action follow‐up requests on adverse events, serious adverse events, and pregnancies.
* Develop and deliver pharmacovigilance training to internal teams and external partners, building capability across the organization.
* Prepare for and support audits and inspections, maintaining the highest standards of documentation and compliance.
* Collaborate across Sales, Marketing, Medical, Clinical, Regulatory Affairs, and Patient Support teams to embed safety considerations into all activities.
Pharmacovigilance resides at the intersection of patient safety, regulatory compliance, and commercial success. You will be part of the Oceania team responsible for ensuring our expanding portfolio of medicines—from diabetes and obesity treatments to rare disease therapies—meets rigorous safety standards.
Skills & Qualifications
* A degree in biological or chemical sciences, pharmacy, or a related 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; experience working across multiple internal teams and with external partners and regulators.
* Ability to work independently, prioritize effectively, and remain composed in a dynamic, fast‐paced environment where patient safety is paramount.
Benefits
As a global healthcare company, we offer opportunities for continuous learning and development, and benefits designed with your career and life stage in mind.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
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