1. Manage the collection, processing, documentation, reporting follow-up of all adverse event reports fall Novartis products from Clinical Trials, Non-interventional Studies, Patientiented Program (POPs), Literature, Spontaneous Reports, any other source of information. 2. Transcribe, translate, enter data from source documents safety systems accurately consistently with focus quality on timeliness. When case processing activities are externalized, liaise with the respective External Service Providers to ensure Novartis Procedures’ compliance. 3. Manage reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR,IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) and/clinical operations in cooperation with other Countryganization Departments. 4. Develop, update, implement local procedures to ensure compliance with Patient Safety global procedures national requirements. 5. Interact 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. 6. Management distribution of vigilance clauses to other departments (such as Legal, Procurement, etc.) to be included in local agreements if necessary 7. Advice the owners of local contracts/ agreements with impact in the vigilance system, about the vigilance provisions to be included, as required per Novartis procedures and/applicable regulations. 8. 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 endorsed by the global PS Alliance group. 9. Perform reconciliation with other departments (e.g., Medical Information, Quality Assurance, Third-party contractors, as applicable) fpotential AEs resulting from medical inquiries, quality related complaints other sources. 10. Management maintenance of all relevant local Patient Safety databases 11. Ensure that relevant local literature articles are screened as appropriate. 12. Prepare submit KPI reports on compliance in a timely manner including identification of root cause(s) flate reporting to LHA, development implementation of corrective action(s) as needed. 13. Develop training materials fvigilance ensure training of Countryganization associates on relevant Patient Safety procedures fAE reporting, including field force thirdparty contractors, as applicable. 14. Ensure support to the internal audits, LHA inspections implementation of the respective CAPA plan 15. Other agreed tasks assigned by manager
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