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 communications with regulatory authorities, and oversee local pharmacovigilance activities while working remotely.

Key responsibilities

• Manage prompt communication with the Marketing Authorisation Holder and local regulatory authorities
• Oversee local pharmacovigilance activities, including collection and reporting of adverse drug reactions
• Support the development and implementation of local pharmacovigilance systems in compliance with global standards

Required qualifications

• Bachelor's Degree in Life Sciences, Chemistry, Nursing, or equivalent experience
• At least 3 years of pharmacovigilance or safety-related experience in a pharmaceutical or regulatory environment
• Good understanding of ICH GVP and local pharmacovigilance requirements
• Experience in case handling or literature screening is preferred
• Proficiency in English; additional language skills are advantageous