Roles and Responsibilities
1. Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from clinical trials, non-interventional studies, Patient Ori-ented Programs, literature, Spontaneous Reports, etc. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with empha-sis on timeliness and quality.
2. 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.
3. Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data.
4. Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional groups and third party contractor, if applicable.
5. Survey and monitor national pharmacovigilance regulations and provide update to global Patient Safety organization.
6. Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
7. Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.
8. Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
9. Management and maintenance of all relevant Patient Safety databases.
10. Ensure that relevant local literature articles are screened as appropriate.
11. 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.
12. Develop and update training materials for pharmacovigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third party contractor, if applicable.
13. Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections.
14. Ensure training and oversight of staff, as applicable.
15. Manage and maintain efficient Patient Safety filing and archive system.
16. Review of all Phase IV Clinical Trial and NIS protocols safety sections and if a Contract Re-search Organization (CRO) is conducting the trial, review the contract (SSW), train the CRO associates responsible from the trial
17. *Drives the local execution of the Risk Management Plans (RMP) for all Novartis group prod-ucts in (insert Country Organization):
• Ensures training on RMP principles and RMP product specifics of Country Organization staff (incl. Sales/Marketing staff) involved in the implementation of the RMP
• Supports the Drug Safety Responsible in the timely and compliant execution locally of the Pharmacovigilance activities defined in the RMP
• Liaises with the other departments in the Country Organization such as Clinical Re-search Operations, Medical, Regulatory Affairs or Sales/Marketing to ensure alignment of all local functions in support of the RMP
• Liaises with Sales/Marketing to ensure implementation of educational materials
18. *Liaises with Local Regulatory Affairs to ensure tracking of status of the RMP commitments implemented locally
19. And other agreed tasks assigned by manager