Pharmacovigilance (Case Processing) Specialist (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

Requirements: Bachelor’s degree in Life Sciences field Minimum 1 year of experience in pharmacovigilance or safety case processing within the pharmaceutical or CRO industry Fluency in Mandarin Chinese (Simplified Chinese) and English , with the ability to process pharmacovigilance safety cases originating in Mandarin, is required Hands-on experience with Argus Safety, Veeva Vault or similar safety databases is preferred Strong proficiency in MS Office applications Ability to work independently while managing multiple cases and deadlines Candidates may be based in or outside China; those located in Europe or other regions and willing to work in European working hours are welcome

Benefits: International team and environment Remote/home-based position Monthly bonuses