- Established in the 1990’s, this organisation is an Australian owned pharmaceutical manufacturer who supports the health of Australians by supplying over 60 medicines in critical therapeutic areas.
- Together with manufacturing medicines, they collaborate with hospitals in developing sought after treatment solutions with a focus on hospital specialty pharmaceuticals.
- If environmental sustainability is important to you, this company is committed to protecting and improving the environment. To dramatically reduce its carbon footprint, they are implementing wide ranging and innovative energy efficiency initiatives.
- An equal opportunity employer, this organisation is driven by upholding strong values.
- A company driven by family values and care for its people.
Reporting to the Chief Global Medical & Regulatory Officer, this Global Pharmacovigilance & Medical Information Manager role will have you:
- Leading end-to-end global Pharmacovigilance and Medical Information activities across Australia, New Zealand, Europe, Canada and other international markets
- Acting as the Pharmacovigilance contact person ensuring all PV systems, processes and reporting activities remain compliant with TGA, Medsafe and global regulatory requirements
- Taking ownership of the company’s Pharmacovigilance System, including driving continuous improvement initiatives, implementing process enhancements and maintaining PV compliance frameworks
- Authoring, reviewing and maintaining critical PV and risk management documentation including PSURs, RMPs, PSMFs, CCDS, CCSI, ICSRs and other aggregate safety reports
- Managing signal detection activities, safety data analysis, MedDRA coding and risk management processes to support ongoing patient safety and regulatory compliance
- Leading audit and inspection readiness activities, supporting TGA and international regulatory audits, managing CAPAs and ensuring timely close-out of findings
- Providing hands-on Medical Information support, responding to complex medical enquiries and delivering high-quality scientific and clinical guidance to internal and external stakeholders
- Reviewing and approving promotional and medical materials to ensure compliance with Medicines Australia Code of Conduct, TGA advertising requirements and global standards
- Partnering closely with Regulatory Affairs, Quality, Manufacturing, Commercial and Executive teams to provide strategic medical and safety input across the business
- Supporting product lifecycle activities through medical review, safety oversight and contribution to product evaluations, labelling updates and international product information documentation
- Developing, reviewing and implementing global SOPs, safety agreements and PV procedures to support scalable and compliant global operations
- Delivering training across adverse event reporting, PV obligations, product knowledge and medical compliance to internal teams and third-party partners
- Acting as the in-house medical and PV expert, providing practical guidance, leadership and hands-on operational support in a standalone environment where you’ll truly roll up your sleeves
YOU WILL HAVE THE FOLLOWING TO BE SUCCESSFUL IN LANDING THIS ROLE
- A degree qualification in Pharmacy, Medicine, Regulatory Affairs, Life Sciences, Public Health or similar
- 5–7+ years’ recent Pharmacovigilance, Medical Information and/or Drug Safety experience
- Strong AU/NZ PV regulatory knowledge including TGA and Medsafe requirements
- Demonstrated experience across both PV and MI functions within regulated pharmaceutical environments
- Proven experience authoring key PV documentation including PSURs, RMPs, PSMFs, CCDS, CCSI and ICSRs
- Experience with signal detection, aggregate safety reporting, risk management activities and MedDRA coding
- Hands-on experience improving PV systems, SOPs and compliance processes
- Experience supporting regulatory audits, inspections and CAPA activities
- Working knowledge of global PV activities and international regulatory environments
- A hands-on approach with the ability to operate independently in a standalone environment
- Strong communication and stakeholder management skills across Regulatory, Quality, Commercial and Executive teams
- Full Australian working rights with the ability to work onsite in Lane Cove West, Sydney
- Willingness to complete a police check, medical assessment and provide evidence of COVID-19 vaccination
Interested? Please 'apply now' quoting reference number 3842 or call Nicole Villanueva on 0414 919 461. Please note, your details/resume will not be sent anywhere without a formal interview and, if successful, your subsequent prior permission. Personal information provided will be used for recruitment purposes only and be treated in the strictest confidence. Only shortlisted candidates will be contacted.