Your responsibilities include, but are not limited to:
• Monitors and audits the company’s drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations.
• 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.
• May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.
• Ensure compliance with Novartis global and local procedures, national and international regulatory requirements in the assigned Region/Countries
• Acts as a key Partner for Global and Local Novartis Patient Safety 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
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
• 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
• People Leadership Operations Management and Execution Collaborating across boundaries People Challenges Managing Crises
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
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