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 while managing communication with the Marketing Authorisation Holder and local authorities, all in a remote capacity.

Key responsibilities

• Communicate promptly and effectively with the Marketing Authorisation Holder and local regulatory authorities
• Provide local regulatory intelligence and expert advice while managing risk minimization measures related to safety issues
• Oversee local pharmacovigilance activities, including reporting suspected adverse drug reactions and maintaining accurate documentation

Required qualifications

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