343133BR
Apr 06, 2022
South Korea

Job Description

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 Orient-ed 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 (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 Pa-tient 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 South Korea:
• 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
20. Develop draft local RMP/PSUR aligned with latest global RMP/PSUR and RMP implementa-tion/assessment Report according to local regulation and coordinate internal review and final-ize for submission to LHA.
21. Ensure reporting and follow up of all spontaneous adverse events (AE) and technical com-plaints for all Novartis group’s products according to respective SOP.

Key Performance Indicators

1. Quality and timely reporting of KPI and safety reports/updates and local RMP/PSUR

2. No critical findings in audits or inspections.

3. Customer feedback



Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Ideal Background
Education (minimum/desirable): Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist) or equivalent education, training and experience

Languages:
• Fluent in both written and spoken English
• Fluent in both written and spoken local language
Experience/Professional requirement:
• Knowledge of national and international regulations for pharmacovigilance
• Knowledge of pharmacological and medical terminolo-gy.
• Excellent communications, interpersonal and negotia-tion skills
• Quality and focus oriented
• Computer skills
• Additional educational requirements as may be man-dated by national requirements
Global Drug Development
CMO & PATIENT SAFETY GDD
South Korea
Seoul
Research & Development
Full Time
Regular
No
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343133BR

Patient Safety Specialist

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