Senior Pharmacovigilance Associate

About the role

As a Senior Pharmacovigilance Associate based in North Sydney, you will act as the guardian of patient safety across Oceania. You will ensure that Novo Nordisk’s medicines are delivered in compliance with local and global pharmacovigilance standards for Australia, New Zealand and surrounding territories.

Key responsibilities

• Serve as backup Local Safety Responsible Person and Qualified Person for Pharmacovigilance (QPPV) for Oceania, maintaining continuity of critical safety functions.
• Monitor and interpret local pharmacovigilance regulations (TGA, Medsafe) and translate them into practical processes.
• Manage safety case reporting to regulatory authorities, including adverse events, serious adverse events and pregnancies.
• Oversee the affiliate safety mailbox and coordinate follow‑up actions with Global Patient Safety.
• Develop and deliver pharmacovigilance training to internal teams and external partners.
• Prepare for and support audits and inspections, ensuring high‑quality documentation and compliance.
• Collaborate with Sales, Marketing, Medical, Clinical, Regulatory Affairs and Patient Support to embed safety considerations throughout the product lifecycle.

Required profile

• Degree in biological, chemical, pharmacy or medical sciences.
• Significant experience in pharmacovigilance within the pharmaceutical industry.
• Strong knowledge of Australian (TGA) and New Zealand (Medsafe) regulatory requirements and international PV standards.
• Excellent attention to detail and documentation skills.
• Effective communication and stakeholder management abilities.

Required skills

• Pharmacovigilance
• Regulatory reporting (TGA, Medsafe)
• Safety case processing