Australia Licensed Pharmacovigilance Specialist

Job Summary

Acting as the primary local representative for pharmacovigilance and regulatory affairs, the full-time Australia Licensed Pharmacovigilance Specialist will ensure compliance with national regulations, manage communication with local authorities, and oversee local pharmacovigilance activities while working remotely.

Key responsibilities

• Communicate promptly and effectively with the Marketing Authorisation Holder (MAH) and local regulatory authorities
• Provide local regulatory intelligence and expert advice while managing risk minimization measures related to safety issues
• Maintain accurate records, support audits, and prepare documentation for regulatory submissions

Required qualifications

• Bachelor's Degree in Life Sciences, Chemistry, Nursing, or equivalent professional experience
• At least 3 years of pharmacovigilance or safety-related experience in a pharmaceutical, CRO, or regulatory environment
• Good understanding of ICH GVP and local pharmacovigilance requirements
• Experience in case handling or local pharmacovigilance activities is preferred
• Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint