Patient Safety Specialist

Your responsibilities include, but are not limited to:

• Lead collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports, etc.
• Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.
• Lead the reporting and submission of safety reports to the Local Health Authorities (LHA) and/or clinical operations in collaboration with other Country Organization Departments.
• Work with other local and global Patient Safety associates to ensure accurate evaluation of safety data.
• Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional groups and third-party contractors, if applicable.
• Survey and supervise national pharmacovigilance regulations and provide update to global Patient Safety organization.
• Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
• Input, review and approval of program proposals for language, content and establishment of vital controls on collection and reporting of adverse event information.
• Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources