Do you have the expertise to manage safety data, report adverse events to health authorities, and uphold high standards of quality control? In this impactful role, you''ll also develop training programs and prepare for audits, all while supporting global Pharmacovigilance requirements. If you''re passionate about safety and compliance in the healthcare field, this is the opportunity for you. Join us as a Pharmacovigilance Associate and play a vital role in ensuring safety and compliance across Oceania! Be a part of the team and apply today!About the departmentYou will be part of Novo Nordisk Oceania, covering Australia and New Zealand. Novo Nordisk is a global healthcare company with over 100 years of innovation in diabetes care. This heritage has equipped us to help people defeat obesity, haemophilia, growth disorders, and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs over 64,000 people in 80 countries and markets our products in more than 170 countries. Join a dynamic and collaborative team devoted to making a difference.The role will be reporting directly to the Senior Pharmacovigilance Manager.The positionAs a Pharmacovigilance Associate, you are to ensure compliance with Oceania (Australia and New Zealand, including relevant territories) and Novo Nordisk global requirements for Pharmacovigilance (PV).Other role expectations are as follows but are not limited to: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.QualificationsDegree level or equivalent in biological/chemical sciences, pharmacy, or a medical sciences discipline.1 year of pharmacovigilance experience in the pharmaceutical industry (desirable).A team player with the ability to work across functions.Must have full working rights to work in Australia.Working at Novo NordiskWe are a proud life-science company, and life is our reason to exist. Were inspired by life in all its forms and shapes, ups and downs, opportunities. For employees at Novo Nordisk, life means many things from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why were all here - to ensure that people can live a life free of chronic disease.ContactPlease send your CV online (click on Apply and follow the instructions).DeadlineApplications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. First Nations peoples are encouraged to apply.At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds, and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and the communities we operate in. Together, were life-changing.#LI-AMS1 #J-18808-Ljbffr
Job Title
Pharmacovigilance Associate