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    Pharmacovigilance Specialist - Sydney, Australia - Healthcare Professionals Group

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    Full time
    Description

    Benefits

    • Lead PV/MDV compliance, contributing to product safety and regulatory excellence.
    • Dynamic work environment with a focus on professional development and work-life balance.
    • Competitive salary package + company benefits



    About the Company
    My client is a global pharmaceutical company specializing in innovative medical products. They have a strong presence in Australia and New Zealand, known for their commitment to quality and cutting-edge research.

    About the Opportunity
    In this role, you will manage Pharmacovigilance activities for Australia and New Zealand, ensuring compliance with regulations and contributing to global projects. Reporting to a senior manager locally you'll play a crucial role in maintaining product safety and regulatory compliance, impacting the business's success in the market.

    Duties

    • Manage PV documentation and ensure compliance.
    • Participate in audits and implement corrective actions.
    • Develop and deliver PV training materials.
    • Manage ADR case reporting and compliance.
    • Act as local responsible person for PV/medical device vigilance compliance.
    • Collect, assess, and report PV/MDV cases.
    • Perform local medical assessments and report to authorities.
    • Interact with stakeholders on safety-related matters.
    • Manage and update QMS documentation.
    • Collaborate on regulatory submissions and audits.
    • Provide regulatory intelligence and contribute to SOPs.



    Skills and Experience

    • Tertiary degree in Pharmacy, Biomedical Science, Nursing or related healthcare degree
    • 2-3 years of experience within pharmacovigilance
    • Good understanding of pharmacovigilance regulations and guidelines
    • A fast and willing learner with a strong attention to detail
    • Adaptable, proactive, strong communication & collaboration skills

    Culture
    Our culture is collaborative, innovative, and focused on making a positive impact in the healthcare industry.

    How to Apply
    Click 'Apply' or contact Gemma Staddon, Specialist Manager on for a confidential discussion.



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