This role acts as the liaison between Patient Safety & Pharmacovigilance (PS&PV) end users in the China country organization and technology service delivery partners. The position is responsible for enhancing Patient Safety & Pharmacovigilance business processes through the implementation of appropriate IT methods and configurations. The role oversees and manages Novartis China PS&PV systems and data science & analytics activities to ensure compliance with international/local regulations, standards, and guidelines as well as Novartis global and local procedures for PS&PV. Leads continuous improvement and process automation of PS&PV activities through the implementation of technology solutions.

Key responsibilities:

•Serves as the primary contact within PV Systems Management for the implementation and configuration of technology solutions for PS&PV in China.

•Proactively identifies opportunities to enhance PS&PV business processes through the application of appropriate IT methods.

•Understands complex business requirements, including China-specific regulatory needs, and identifies innovative technology solutions to achieve key business objectives.

•Provides operational support for safety database users, addressing complex requirements.

•Drive operational efficiency through innovative solutions

effective usage of new technologies and concepts

developing new analysis opportunities by integrating existing and new data sources.

•Lead automation of Safety data reports, line listings management, including consultation, verification and generation.

•Manage system or technology related implementation and upgrade projects, to ensure quality and improve efficiency of PS&PV activities through the usage of enterprise platforms and innovative technologies.

•Acts as the main liaison with internal IT functions for projects and operational support for country specific needs.

•Leads discussions with global business functions, internal IT functions and software vendors to resolve operational issues and to develop solutions.

Essential requirements：

•Degree in Life Sciences or Information Technology

•Fluent in spoken and written Mandarin and English

•Minimum of 8 years of experience in the pharmaceutical industry, preferably in Patient Safety.

•At least 5 years of experience in an international, cross-functional environment, including the management of external providers.

Desirable requirements：

•In-depth understanding of technology system operations with knowledge of Oracle Argus system administration and operation.

•Comprehensive knowledge of Patient Safety, Clinical Development, Quality, and Regulatory standards and policies relevant to PS&PV functions, as well as familiarity with operational and scientific aspects of drug development.

•High degree of competency and experience with the China specific digital ecosystem and technology relevant to the life-sciences and pharmaceutical sector.

•A minimum of 3 years’ experience working on IT projects, with a strong grasp of aligning technology with business needs.

•Proven experience in supporting regulatory inspections, responding to inspectors, and managing related team actions.

•Strong interpersonal and leadership skills.

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Team Management

Clinical Trial

Employee Training

Databases

Pharmacovigilance

Safety Science

Reporting

Waterfall Model