Pharmacovigilance; Case Processing Specialist; Mandarin language
Position: Pharmacovigilance (Case Processing) Specialist (Mandarin language) Location: Town of Italy Overview Biomapas & Delta PV are 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. 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 Qualifications • 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 #J-18808-Ljbffr Apply tot his job