Regional Patient Safety Manager Europe

Job Description Summary

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic areas and platform depth and capabilities – all to bring our medicines to patients even faster. We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to. Apply today - we will thrive together!

Job Description

Purpose:

Are you ready to step up and become the Regional Patient Safety Manager of Europe? In this role you will monitor and audit the PV system in Europe for a subcluster of countries. This will involve, intake, evaluation, processing and follow-up on adverse reports. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. Supports all clinical trial activity and post marketing.

Key requirements:

• Ensure compliance with Novartis global and local procedures, national and international regulatory requirements in the assigned European Region/Countries -Acts as a key Partner for the European Regional Head PV in order to drive safety processes excellence -Drives compliance including coordination and execution of new Novartis and/or regulatory requirements and inspection readiness via Local Novartis Patient Safety teams.

• Facilitate sharing of information and best practices -Track and measure workload and productivity to optimize resource utilization and capabilities -Assess the performance of their direct reports, and support in their development.

• Adherence to Novartis policy and guidelines -Project & stakeholder feedback -Operational risk mitigation and audit/inspection findings -Quality and timely reporting of KPI and safety reports/updates -Results of audits/inspections.

Your Experience:

• Degree in life sciences or pharmacy with a validated level of experience working in the pharmacovigilance arena.

• Ability to lead crisis, people leadership, solid operational management and stakeholder collaboration experience.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Commitment to Diversity & Inclusion :

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

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Skills Desired

Clinical Research, Clinical Trials, Leadership, Regulatory Compliance, Safety Science, Strategy #J-18808-Ljbffr