Pharmacovigilance Associate

Description

• 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.