Patient Safety and Risk Management Specialist

hace 7 días


Santiago, Metropolitana, Chile CL01 (FCRS = CL001) Novartis Chile S.A. A tiempo completo

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:
  1. End-to-end management of assigned pharmacovigilance processes across Novartis Divisions.
  2. Responsible for ensuring compliance to global regulatory requirements with maximum efficiency.
  3. Lead assigned cross-functional patient safety projects.
  4. Author and maintain procedural documents for assigned processes and drive continuous improvement by alignment of relevant stakeholders globally and locally.
  5. Develop and maintain training material and communications for Novartis group and third-party associates.
  6. Support impact assessments on emerging regulations and ensure ongoing compliance to global regulatory requirements.
  7. Lead assigned process improvement initiatives, including IT projects/systems (leading enhancements and managing releases).
  8. Analyze the impact of other process and organizational changes.
  9. 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.
  10. In the case of any delays, investigate the root cause and develop and implement corrective and preventative actions.
  11. Measure effectiveness of actions taken.
  12. 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.
  13. Resolve queries from other functions and Country Organizations (COs) related to assigned processes and act as a consultant on regulatory requirements.
  14. Mentor and train new starters.


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