Senior Pharmacovigilance Associate

4 days ago

Sydney, New South Wales, Australia i-Pharm Consulting Australia Pty Ltd Full time $120,000 - $180,000 per year
Senior Pharmacovigilance Associate

Location: Sydney (Australia & New Zealand coverage)

Contract: 6 months (immediate start)

Industry: Global leader in pharmaceuticals


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: -

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