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Role Purpose
To support management of Patient Safety operational processes at Country Organization ensuring com-pliance with Novartis global and local procedures, national and international regulations/ standards/ guide-lines for vigilance of both marketed and investigational products (incl. drugs, food supplements and medi-cal devices) from Novartis Group.
Major Accountabilities
1. Manage the collection, processing, documentation, reporting and follow-up of all adverse event re-ports for all Novartis products from Clinical Trials, Non-interventional Studies, Patient Oriented Pro-gram (POPs), Literature, Spontaneous Reports, and any other source of information.
2. Transcribe, translate, and enter data from source documents into safety systems accurately and con-sistently with focus quality and 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/or clinical operations in cooperation with other Country Organization Departments.
4. Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
5. Interact and collaborate with other departments (such as Medical Affairs, Marketing, Patient Engage-ment, 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 and 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 vigi-lance provisions to be included, as required per Novartis procedures and/or applicable regulations.
8. Ensure compliance with the commitments disposed in the contracts/ agreements. Ensure the applica-ble local contracts/ agreements are tracked in the respective Pharmacovigilance Agreement Share-Point. Ensure any significant departure from the standard vigilance templates are communicated and endorsed by the global PS Alliance group.
9. 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 relat-ed complaints and other sources.
10. Management and maintenance of all relevant local Patient Safety databases
11. Ensure that relevant local literature articles are screened as appropriate.
12. Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed.
13. Develop and update training materials for vigilance and ensure training of Country Organization asso-ciates on relevant Patient Safety procedures for AE reporting, including field force and third-party con-tractors, as applicable.
14. Ensure support to the internal audits, LHA inspections and implementation of the respective CAPA plan
