Patient Safety Specialist
vor 6 Tg.

927 million. That’s how many lives our products touched in 2017. And while we’re proud of that, in this world of digital and technological transformation, we must also ask ourselves this : how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.

We are Novartis. Join us and help reimagine medicine.Currently we are looking for our new colleague for a part-time (50%), temporary position in our Patient Safety Team.

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).

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. 2. Manage reporting / submission / distribution of safety reports / updates / information 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 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 16.

Drives the local execution of the RMP for all Novartis group products in Hungary 17. Liaises with Local RA to ensure tracking of status of the RMP commitments implemented locally

Minimum requirements

  • Education : Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist).
  • Fluent in both written and spoken English and Hungarian* 0-5 year of relevant experience
  • Temporary

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