We are delighted to be partnering with this specialist pharmaceutical company to appoint their Medical Information & PV Manager, a pivotal role encompassing a range of medical responsibilities while overseeing the function at a senior level within a high‐accountability Australian affiliate. This is an outstanding opportunity for an experienced Medical Affairs professional seeking breadth, autonomy, and visibility, with direct interaction across global teams, regulatory authorities, and external vendors.
The business has been operating in Australia for over a decade, delivering treatments in hormonal therapies. The organisation is recognised for its expertise and advanced delivery methods. With a niche, patient‐centric approach and focused portfolio, it differentiates itself from larger pharma companies, positioning the business well for continued growth in Australia, particularly with increasing demand in women's health and preventative care.
Reporting To The Medical Director: Your Responsibilities Will Include
* Act as the local lead for Medical Information and Pharmacovigilance, ensuring compliance with Australian and global requirements
* Deliver accurate and timely medical responses while maintaining MI systems, databases, and reporting processes
* Oversee adverse event reporting, reconciliation, and vendor performance, acting as the key contact with regulators and global teams
* Lead local Quality activities, including maintaining the QMS and supporting audits, inspections, complaints, and recalls (small percentage of the role)
* Manage stakeholder relationships, including external vendors, consultants, and cross‐functional internal teams
* Provide broader support across projects, including investigator‐initiated trials and representation at scientific meetings.
To Thrive In This Role, You'll Bring
* Bachelor of Pharmacy or relevant life sciences degree (required)
* Extensive experience in Medical Information and Pharmacovigilance, with strong knowledge of Australian regulatory and PV requirements
* Experience working with pharmaceutical quality systems and compliance frameworks
* Comfortable managing vendors, audits, and external stakeholders
* Excellent written and verbal communication skills with an entrepreneurial mindset
* Strong documentation discipline and scientific judgement, with a sound understanding of governance, compliance, and regulatory frameworks
* Confident working with global teams and third‐party partners
This role offers a rare opportunity to take ownership of end‐to‐end Medical, Pharmacovigilance operations, with high visibility, genuine autonomy, and the ability to shape and strengthen local systems while partnering closely with global teams.
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