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 communications with local regulatory authorities and supporting the Marketing Authorisation Holder throughout the product lifecycle, with the opportunity to work remotely.

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
• Collect and report suspected adverse drug reactions and maintain accurate local records and documentation

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