warning
İlan yayından kaldırılmıştır
İstanbul(Asya)

İş Yerinde

İş Yerinde

Job Type

Full-Time

Position Level

Specialist

Department

Health / Medical

Health / Medical

Application Count

497 application

Job Type

Full-Time

Position Level

Specialist

Application Count

497 application

Department

Health / Medical

QUALIFICATIONS AND JOB DESCRIPTION

Job Purpose  

 

To support management of Patient Safety operational processes at Country Organization in ensuring compliance withNovartis global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilanceof Novartis group marketed and investigational products (drugs and devices).

 

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 ofCountry 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 efficientPatient 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

 

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

Preferred Candidate

More than 2 years of experience
Bachelor’s(Graduate), Master’s(Student), Master’s(Graduate), Doctorate(Student), Doctorate(Graduate)
Completed, Exempt
English(Reading : Advanced, Writing : Advanced, Speaking : Advanced)

Farmakovijilans Uzmanı pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.

Farmakovijilans Uzmanı Farmakovijilans Uzmanı Maaşları Farmakovijilans Uzmanı Nasıl Olunur? Farmakovijilans Uzmanı Nedir? Farmakovijilans Uzmanı İş İlanları
Hakkımızda

Novartis Sağlık, Gıda ve Tarım Ürünleri San.

Şirket Sayfasına Git

Farmakovijilans Uzmanı pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.

Farmakovijilans Uzmanı Farmakovijilans Uzmanı Maaşları Farmakovijilans Uzmanı Nasıl Olunur? Farmakovijilans Uzmanı Nedir? Farmakovijilans Uzmanı İş İlanları