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, communicate with local regulatory authorities, and support the Marketing Authorisation Holder in maintaining product compliance throughout its lifecycle, with the opportunity to work remotely.

Key responsibilities

• Communicate promptly and effectively with the Marketing Authorisation Holder and local regulatory authorities
• Manage local pharmacovigilance and regulatory activities, including reporting of adverse drug reactions and compliance documentation
• Provide local regulatory intelligence and support the development of the pharmacovigilance system in compliance with global standards

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, CRO, or regulatory environments
• Understanding of ICH GVP and local pharmacovigilance requirements
• Experience in case handling, literature screening, or local pharmacovigilance activities preferred
• Proficiency in English; additional language skills are advantageous