Lead Pharmacovigilance Specialist

6 days ago

Sydney, New South Wales, Australia beBeeProfessional Full time $90,000 - $120,000
Senior Pharmacovigilance Associate Role Overview

We are seeking a seasoned pharmacovigilance professional to lead our team in shaping and executing pharmacovigilance activities for Australia and New Zealand.

Key Responsibilities:
  • Collaborate with stakeholders to enable regulatory compliance and drive business objectives.
  • Develop and implement risk management plans and annexes to ensure compliance with local regulations.
  • Assess PV impact of sponsored research activities and conduct training on PV requirements.
  • Review PV agreements and contracts with vendors.
  • Monitor, review, and implement PV regulatory requirements.
  • Implement clinical trials safety monitoring plans.
  • Collaborate with case management teams.
Requirements:
  • Tertiary qualification in pharmacy, life science, or pharmaceuticals.
  • Pharmacovigilance experience in the pharmaceutical industry.
  • Strong stakeholder management skills and ability to achieve business deliverables.
  • Comprehensive understanding of Australian and New Zealand pharmacovigilance requirements and global drug safety aspects.
  • Experience with Global Medical Safety database systems.
  • Preferred qualifications include case management experience, PV compliance oversight, and RMP/ASA development.
Company Benefits:

Competitive remuneration package, continuous training, support, and award-winning leadership development programs.

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