Job Details:
To support management of DS&E/PVO operational processes at Country Pharma Organization (CPO) in ensuring compliance with Novartis global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of Novartis marketed and investigational products.
1. Manage collection, processing, documentation, reporting and follow-up of all serious adverse events (SAE) reports for all Novartis products from clinical trials, and all adverse events from Patient Oriented Programs, post-marketing studies (PMS), registries, and all Spontaneous Re-ports (SR).
2. Transcribe, translate and enter data of all Serious Adverse Events (from Clinical Trials,) and all adverse events (from Patient Oriented Programs, post-marketing studies (PMS), registries and all Spontaneous Reports) from source documents onto safety systems (e.g. Argus Affiliate, etc) accurately and consistently with emphasis on timeliness and quality.
3. Record and track receipts, submissions and distributions of SAEs, SRs, Investigator Notifica-tions (IN), SUSARs, Periodic Safety Report Updates (PSUR) and Development Safety Update Report (DSUR) in cooperation with other CPO Departments.
4. 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 CPO Departments.
5. Work with other local/global PVO associates to ensure accurate evaluation of safety data.
6. Interact and exchange relevant safety information with LHA, PVO associates, other functional groups and third party contractor, if applicable.
7. Survey and monitor national pharmacovigilance regulations and provide update to global PVO organization.
8. Develop, update and implement local procedures to ensure compliance with PVO global procedures and national requirements.
9. Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.
10. Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries and quality related complaints.
11. Management and maintenance of all relevant PVO databases.
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 pharmacovigilance and ensure training of CPO as-sociates on relevant PVO procedures for AE reporting, including field force and third party contractor, if applicable.
14. Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections.
15. Ensure training and oversight of staff, as applicable.
16. Manage and maintain efficient PVO filing and archive system.
17. Review of all Phase IV Clinical Trial and PMS protocols safety sections and if a Contract Re-search Organisation (CRO) is conducting the trial, review the contract (SSW), train the CRO associates responsible from the trial
18. Acts as DSR Deputy: functional (in terms of responsibility for PV system) and operational (in terms of managing the DS&E Team)...
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