Novartis İlaç

Patient Safety Specialist

 

 

Job Description

We are looking for team members who is energetic, curious and innovative for our Patient Safety Department. 

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).

Responsibilities

 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 Ori-ented Programs, literature, Spontaneous Reports, etc. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with empha-sis 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 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 (insert Country Organization):

• 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

Qualifications

 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

About Us

Novartis is a global pharmaceutical company, centered in Switzerland. It has approximately 100.000 employees all over the world and 2.400 employees in Turkey. Novartis was created in 1996 through a merger of Ciba-Geigy and Sandoz. Novartis and its predecessor companies trace roots back more than 250 years, with a rich history of developing innovative products. Our products are available in 155 countries and we touched 1 billion lives with our products in 2019. Novartis is structured to deliver innovative products, exploit global scale, and respond to new opportunities and risks. Our divisions - Innovative Medicines, and Sandoz - are supported by functional organizations with global scale. 

Want to know more about Novartis İlaç ?
Review Profile