Location: Copenhagen, Denmark (hybrid)

About this role:

Join our team as a Patient Safety Specialist and be at the forefront of ensuring the safety of patients worldwide. In this exciting role, you will play a vital part in supporting the management of operational processes related to patient safety at the Country Organization. Your focus will be on ensuring compliance with Novartis global and local procedures, as well as national and international regulations, standards, and guidelines for the vigilance of both marketed and investigational products. This includes drugs, food supplements, and medical devices within the Novartis Group. This role reports to Cluster Patient Safety Head Nordics.

Key Responsibilities:

• Manage the collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from Clinical Trials, Non-interventional Studies, Patient Oriented Program (POPs), Literature, Spontaneous Reports, and any other source of information.
• Transcribe, translate, and enter data from source documents into safety systems accurately and consistently with focus quality and on timeliness. When case processing activities are externalized, liaise with the respective External Service Providers to ensure Novartis Procedures’ compliance.
• Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
• Interact and collaborate with other departments (such as Medical Affairs, Marketing, Patient Engagement, etc.) to ensure that any projects/ initiatives that potentially involve safety data collection (POPs, DEAs, SM/SML, etc.) follow the Novartis vigilance requirements.
• Ensure compliance with the commitments disposed in the contracts/ agreements. Ensure the applicable local contracts/ agreements are tracked in the respective Pharmacovigilance Agreement SharePoint. Ensure any significant departure from the standard vigilance templates are communicated and endorsed by the global PS Alliance group.
• Perform reconciliation with other departments (e.g., Medical Information, Quality Assurance, and Third-party contractors, as applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
• Develop and update training materials for vigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third-party contractors, as applicable.
• Ensure support to the internal audits, LHA inspections and implementation of the respective CAPA plan