Local Contact Person – Pharmacovigilance, Regulatory Affairs

• Act as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA)
• Serve as the primary local Regulatory Affairs and Pharmacovigilance representative for Australia
• Ensure compliance with national pharmacovigilance and regulatory requirements
• Execute local pharmacovigilance and regulatory affairs activities
• Support the Marketing Authorisation Holder in maintaining product compliance throughout its lifecycle
• Communicate promptly and effectively with the Marketing Authorisation Holder and local regulatory authorities
• Serve as the primary contact for local regulatory authorities on Regulatory Affairs and Pharmacovigilance matters
• Screen local regulatory intelligence and provide expert advice for responsible regions
• Collect and report locally suspected adverse drug reactions and individual case safety reports, including follow-ups and translations
• Manage or oversee risk-minimization measures related to urgent safety restrictions and emerging safety issues
• Support development and implementation of the local pharmacovigilance system in compliance with the global system and local regulations
• Perform local non-indexed literature screening and regulatory-authority website screening for potential adverse drug reactions and safety information
• Maintain accurate local records and documentation
• Support the Regulatory Affairs and Pharmacovigilance Global Operations team
• Prepare and collect documentation for regulatory-authority submissions
• Review and provide linguistic input on local Product Information and mock-ups
• Ensure compliance with Marketing Authorisation Holder and PrimeVigilance procedures
• Support audits and inspections
• Handle local quality-assurance tasks, including suspected falsified products, health-authority quality alerts and other local-market quality requirements

• Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience
• At least 3 years of pharmacovigilance or safety-related experience in pharmaceutical, CRO, or regulatory environment
• Good understanding of ICH GVP and local pharmacovigilance requirements through training or practical exposure
• Experience in case handling, literature screening, or local PV activities is preferred
• Prior experience in Regulatory Affairs is preferred but not mandatory
• Proficiency in English
• Additional language knowledge is advantageous
• Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint
• Ability to act as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs
• Knowledge of national pharmacovigilance and regulatory requirements in Australia
• Ability to support audits and inspections
• Ability to handle local QA tasks, including suspected falsified products and health-authority quality alerts

• Remote work option
• Permanent or contractor employment arrangement
• Collaborative and supportive team environment
• Flexibility, growth and belonging culture
• Opportunity to work with global teams across Europe, North America, South America, Asia and Australia
• Professional growth opportunities
• Purpose-driven work helping protect patients
• Exposure to clinical research, pharmacovigilance and quality consulting experts