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Lead Pharmacovigilance Specialist
3 weeks ago
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.
- 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.