Your Responsibilities Include, but are not limited to:

• Maintain and manage the reporting requirements system (T-Rex), acting as a super user for end users and a key contact for stakeholders.
• Serve as Business System Owner or Deputy System Owner to deliver global strategic initiatives and solutions for Patient Safety and Pharmacovigilance.
• Coordinate timely submission gateway implementations and submissions of ICSRs to Health Authorities, Country Organizations, and License Partners, adhering to current regulatory standards.
• Lead or contribute to global technical projects, cross-functional workshops, and the development, testing, and validation of Safety Systems/IT applications, including drafting related documentation.
• Oversee tasks outsourced to service vendors, providing necessary guidance and training to ensure effective interaction and compliance.
• Identify compliance gaps or discrepancies in ICSR reporting and propose improvements, while ensuring inspection readiness and supporting Health Authority inspections and internal audits.

What you'll bring to the role: 

• Degree in life science or computing subject
• Fluent in spoken and written English. Understanding of another major European language (French, German, Spanish) preferred
• Minimum of 7 years of experience in drug development, with at least 5 years in safety data management, and expertise in Pharmacovigilance systems and databases
• Thorough understanding of reference data for Pharmacovigilance (e.g., medical dictionaries, product and device definitions)
• Broad and in-depth knowledge of Pharmacovigilance and Drug safety business processes, along with excellent mentoring, coaching skills, and the ability to lead and deliver initiatives.

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? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & 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: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network