Patient Safety and Risk Management Specialist
hace 7 días
About the Role:
The Patient Safety Manager plays a critical role in ensuring compliance with global regulatory requirements, managing assigned pharmacovigilance processes, and leading cross-functional patient safety projects. This position requires strong project management skills, attention to detail, and the ability to work collaboratively with stakeholders globally and locally.
Responsibilities:- End-to-end management of assigned pharmacovigilance processes across Novartis Divisions.
- Responsible for ensuring compliance to global regulatory requirements with maximum efficiency.
- Lead assigned cross-functional patient safety projects.
- Author and maintain procedural documents for assigned processes and drive continuous improvement by alignment of relevant stakeholders globally and locally.
- Develop and maintain training material and communications for Novartis group and third-party associates.
- Support impact assessments on emerging regulations and ensure ongoing compliance to global regulatory requirements.
- Lead assigned process improvement initiatives, including IT projects/systems (leading enhancements and managing releases).
- Analyze the impact of other process and organizational changes.
- Work in collaboration with other functions to produce compliance reports and complete quality checks to monitor regulatory compliance as well as compliance to internal requirements.
- In the case of any delays, investigate the root cause and develop and implement corrective and preventative actions.
- Measure effectiveness of actions taken.
- Act as a subject matter expert during audits and inspections (e.g., FDA and EMA), lead the preparation of responses to findings and the development and implementation of corrective and preventative actions.
- Resolve queries from other functions and Country Organizations (COs) related to assigned processes and act as a consultant on regulatory requirements.
- Mentor and train new starters.
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