Pharmacovigilance Specialist (Case Processing / Mandarin language)

Biomapas & Delta PV looking for a Pharmacovigilance (Case Processing) Specialist with Mandarin language.

Pharmacovigilance Specialist will be responsible for the operational delivery of pharmacovigilance activities at the project level, with a primary focus on safety case intake, processing, and reporting. The role involves end-to-end case processing rather than translation, including medical assessment and regulatory compliance activities.

Key Responsibilities:

• Manage and process end-to-end safety case reports in compliance with global and local regulatory requirements
• Perform triage of incoming safety information, assessing case validity, seriousness, and required follow-up actions
• Review, manage, and archive source documentation in accordance with pharmacovigilance regulations and internal SOPs
• Perform safety database (SDB) data entry, including narrative writing and case documentation
• Conduct medical assessments, including seriousness, causality, and expectedness evaluations
• Assess reporting requirements and ensure timely submission to health authorities and clients
• Perform and document follow-up activities and manage safety-related queries
• Execute quality control checks to ensure data accuracy, completeness, and compliance
• Perform reconciliation activities to ensure consistency across safety databases and source documents
• Prepare line listings and safety reports as required by projects or clients