Patient Safety Specialist

5G-Starlink Pte.; Malacca City; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading health safety company is seeking a professional to manage the collection, processing, and reporting of adverse event reports. Key responsibilities include ensuring compliance with pharmacovigilance regulations, transcribing safety data accurately, and collaborating with health authorities and other departments. The ideal candidate will lead efforts in maintaining high standards of data quality and will work in a dynamic environment focused on healthcare safety.

Responsibilities

• Lead collection and reporting of adverse event reports for Novartis products.
• Translate and enter data into safety systems with emphasis on quality.
• Ensure compliance with Patient Safety global procedures and national requirements.

Job description

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.