Novartis Patient Safety Specialist
İlan Tanımı
Job Purpose
To support management of Patient Safety operational processes at Country Organization in ensuring compliance with Novartis global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of Novartis group marketed and investigational products (drugs and devices).
Sorumluluklar
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 Oriented Programs, literature, Spontaneous Reports, etc. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis 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 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. 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.
11. 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.
12. Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections.
13. Ensure training and oversight of staff, as applicable.
14. Manage and maintain efficient Patient Safety filing and archive system.
15. Review of all Phase IV Clinical Trial and NIS protocols safety sections and if a Contract Research Organization (CRO) is conducting the trial, review the contract (SSW), train the CRO associates responsible from the trial
Aranan Nitelikler
Ideal Background
Education (minimum/desirable):
Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist).
Languages:
· Fluent in both written and spoken English
· Fluent in both written and spoken local language
Experience/Professional requirement:
· Minimum 2 years of experience in drug safety
· Knowledge of national and international regulations for pharmacovigilance
· Knowledge of pharmacological and medical terminology.
· Excellent communications, interpersonal and negotiation skills
· Quality and focus oriented
· Computer skills
· Additional educational requirements as may be mandated by national requirements
Ayrıcalıklar
Key Performance Indicators
1. Quality and timely reporting of KPI and safety reports/updates
2. No critical findings in audits or inspections.
3. Customer feedback
