Country Patient Safety Head (m/f/d)

327476BR
Sep 13, 2021
Austria

Job Description

Country Patient Safety Head (f/m/d), Patient Safety – Global Drug Development (GDD), Vienna, Austria

6! This is the number of associates who you will be leading within our Austrian Patient Safety Team. The Country Patient Safety Head is responsible for the management of vigilance processes at Country Organization level in ensuring compliance with global/local Novartis procedures, national and international regulations/standards/guidelines for pharmacovigilance of Novartis marketed and investigational products.

Your key responsibilities:

Your responsibilities include, but are not limited to:
• Create, implement and execute an appropriate strategy for the Patient Safety Organization at the country level (Austria)
• Lead and develop the patient safety associates in your team including all aspects of people management
• Proactively cooperate and collaborate with the Risk Management Plan (RMP) key stakeholders on the implementation of RMP commitments from Patient Safety perspective
• Be involved in the review of all pre- and post-authorization studies
• Proactively liaise with program owners (Social media/Digital/Patient Oriented Programs) and provide advice to ensure appropriate mechanisms to collect, report, manage and reconcile safety information as well as appropriate adverse event trainings to the third-party companies involved
• Advise the owners of agreements with local impact on the pharmaco-device vigilance provisions required
• In cooperation and under leadership with Country Organization QA responsible manage any internal or external pharmacovigilance audits and support in the implementation of any corrective/preventative action

Minimum Requirements

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Global Drug Development
CMO & PATIENT SAFETY GDD
Austria
Vienna
Research & Development
Full Time
Regular
No
327476BR

Country Patient Safety Head (m/f/d)

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