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Lead Pharmacovigilance Specialist

3 weeks ago


Sydney, New South Wales, Australia beBeeDrugSafety Full time $120,000 - $150,000
Job Opportunity

This is an exciting opportunity to lead and partner with key stakeholders to shape and execute pharmacovigilance activities for Australia and New Zealand.

Key Responsibilities
  • Collaborate with local, regional, and global affiliates to ensure regulatory responsibilities are met and business objectives achieved.
  • Develop and implement local Risk Management Plans in compliance with Australian regulations.
  • Assess the impact of company-sponsored research on pharmacovigilance and provide training on requirements to internal stakeholders and vendors.
  • Review contracts with external vendors related to pharmacovigilance.
  • Monitor, review, and implement pharmacovigilance regulatory requirements.
  • Implement Clinical Trials Safety Monitoring Plans.
Requirements
  • Tertiary qualification in pharmacy, life science, or pharmaceuticals.
  • Pharmacovigilance experience in the pharmaceutical industry.
  • Strong stakeholder management skills and ability to deliver business outcomes.
  • Understanding of Australian and New Zealand pharmacovigilance requirements and global drug safety aspects.
  • Experience with Global Medical Safety database systems.