Safety Data Management : Oversee the affiliate safety mailbox and ensure accurate data entry of safety information reports, including forwarding to internal partners as needed.
Regulatory Reporting : Report adverse events and safety cases to Oceania health authorities and manage requests for additional follow-up information from Novo Nordisk Global Safety.
Quality Control and Compliance : Conduct reconciliation and quality checks of safety reports, ensuring good documentation practices in compliance with regulatory and internal standards, including the updates of Oceania PV SOPs and guidelines.
Training and Oversight : Develop and deliver Pharmacovigilance training for internal staff and partners while maintaining oversight of safety information programs and the HALO PV system.
Audit Preparation and Case Management : Prepare for internal and external audits, raise and manage cases in the global deviations system, and ensure the proper handling and archiving of documentation according to retention requirements.
Qualifications
Degree level or equivalent in biological/chemical sciences, pharmacy, or a medical sciences discipline.
Minimum of 1 year of pharmacovigilance experience in the pharmaceutical industry is a requirement.
A team-player and has the ability to work across functions.
Must have full working right to work in Australia.
