Risk Management Lead

7 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $150,000
Pharmacovigilance Specialist

We are seeking a seasoned professional to lead pharmacovigilance activities for Australia and New Zealand. As a Pharmacovigilance Specialist, you will partner with key stakeholders to shape and execute these activities.

Key Responsibilities
  • Collaborate with local operating companies, regional, and global affiliates to ensure regulatory responsibilities are met.
  • Lead cross-functional teams to develop risk management plans in compliance with local regulations.
  • Track oversight of additional risk minimisation activities and commitments.
  • Assess PV impact of related research activities and conduct training on PV requirements.
  • Review PV agreements and other contracts with external vendors.
  • Monitor, review, and implement PV regulatory requirements.
  • Review and implement clinical trials safety monitoring plan.
Requirements
  • Tertiary qualification in pharmacy, life science, or pharmaceutical degree.
  • Pharmacovigilance experience in the pharmaceutical industry.
  • Solid stakeholder management skills and achieving business deliverables.
  • Strong understanding of Australian and New Zealand pharmacovigilance requirements.
  • Understanding of Global Medical Safety database systems.

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