Patient Safety Specialist

4 days ago

Malacca, Melaka, Malaysia 5G-Starlink Pte. Full time 30,000 - 60,000 per year


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

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