Patient Safety Specialist-fixed term contract

at  Novartis

Requirements:

• Scientific degree (preferably Medical Doctor, Nurse, Pharmacist) or experience on similar position.
• Knowledge of national and international regulations for pharmacovigilance
• Knowledge of pharmacological and medical terminology
• Good communication and interpersonal skills
• Fluent in both written and spoken English and Hungarian)
• Quality and results oriented
• Computer skill

ABOUT THE ROLE

Role Purpose
To support management of Patient Safety operational processes at Country Organization ensuring compliance with Novartis global and local procedures, national and international regulations/ standards/ guidelines for vigilance of both marketed and investigational products (incl. drugs, food supplements and medical devices) from Novartis Group.
We offering hybrid contract( 3 days per week working from Budapest office, 2 days from home)
Major Accountabilities:
1. Manage the 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 Program (POPs), Literature, Spontaneous Reports, and any other source of information.
2. Transcribe, translate, and enter data from source documents into safety systems accurately and consistently with focus quality and on timeliness. When case processing activities are ex-ternalized, liaise with the respective External Service Providers to ensure Novartis Procedures’ compliance.
3. 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.
4. Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
5. Interact and collaborate with other departments (such as Medical Affairs, Marketing, Patient Engagement, etc.) to ensure that any projects/ initiatives that potentially involve safety data collection (POPs, DEAs, SM/SML, etc.) follow the Novartis vigilance requirements.
6. Management and distribution of vigilance clauses to other departments (such as Legal, Pro-curement, etc.) to be included in local agreements if necessary
7. Advice the owners of local contracts/ agreements with impact in the vigilance system, about the vigilance provisions to be included, as required per Novartis procedures and/or applicable regulations.
8. Ensure compliance with the commitments disposed in the contracts/ agreements. Ensure the applicable local contracts/ agreements are tracked in the respective Pharmacovigilance Agreement SharePoint. Ensure any significant departure from the standard vigilance tem-plates are communicated and endorsed by the global PS Alliance group.
9. Perform reconciliation with other departments (e.g., Medical Information, Quality Assurance, and Third-party contractors, as applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
10. Management and maintenance of all relevant local Patient Safety databases
11. Ensure that relevant local literature articles are screened as appropriate.
12. 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.
13. Develop and update training materials for vigilance and ensure training of Country Organiza-tion associates on relevant Patient Safety procedures for AE reporting, including field force and third-party contractors, as applicable.
14. Ensure support to the internal audits, LHA inspections and implementation of the respective CAPA plan

ROLE REQUIREMENTS

Requirements:

• Scientific degree (preferably Medical Doctor, Nurse, Pharmacist) or experience on similar position.
• Knowledge of national and international regulations for pharmacovigilance
• Knowledge of pharmacological and medical terminology
• Good communication and interpersonal skills
• Fluent in both written and spoken English and Hungarian)
• Quality and results oriented
• Computer skills

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network