Patient Safety Specialist- Gulf Cluster

دبي - الإمارات

الراتب شهرياً: لم يكشف

تاريخ النشر: نُشرت قبل 10 ساعة

عدد الوظائف الشاغرة: 1 عدد الوظائف الشاغرة

سجل للتقديم

ملخص الوظيفة

Job Description Summary

An exciting opportunity to join our Patient Safety Team as a Patient Safety Specialist. We are welcoming UAE National Talents to apply for this role in which you will work towards supporting 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 medical devices) from Novartis Group.

#LI-Onsite

Job Description

Major Accountabilities:

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 (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 Research 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 products in Gulf Cluster:

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 Research 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

Ideal Background

If you are a UAE National hold a UAE Family Book and are passionate to join an organization that promotes an unbossed diverse and flexible working environment join us.

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 terminology.

Excellent communications interpersonal and negotiation skills

Quality and focus oriented

Computer skills

Additional educational requirements as may be mandated by national requirements

Skills Desired

Databases Employee Training Filing Documents Pharmacovigilance Reporting Safety Science

Required Experience:

Job Description SummaryAn exciting opportunity to join our Patient Safety Team as a Patient Safety Specialist. We are welcoming UAE National Talents to apply for this role in which you will work towards supporting management of Patient Safety operational processes at Country Organization ensuring co...