Regulatory Compliance Specialist
hace 2 días
**About the Role**
We are seeking a highly skilled Regulatory Compliance Specialist to join our team in Novartis Chile S.A. The ideal candidate will be responsible for ensuring compliance with global regulatory requirements, managing pharmacovigilance processes, and leading cross-functional projects.
Main Responsibilities:
- Manage assigned pharmacovigilance processes across Novartis Divisions.
- Ensure 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.
- 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.
Key Performance Indicators:
- 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.
Skills Required:
- Databases.
- Employee Training.
- Project Management.
- Reporting.
- Safety Science.
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