Pharmacovigilance /Case Processing/ Specialist /Mandarin language/

🌍 Remote, USA 🎯 Full-time πŸ• Posted Recently

Job Description

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: β€’ Manage and process end-to-end safety case reports in compliance with global and local regulatory requirements β€’ Perform triage of incoming safety information, assessing case validity, seriousness, and required follow-up actions β€’ Review, manage, and archive source documentation in accordance with pharmacovigilance regulations and internal SOPs β€’ Perform safety database (SDB) data entry, including narrative writing and case documentation β€’ Conduct medical assessments, including seriousness, causality, and expectedness evaluations β€’ Assess reporting requirements and ensure timely submission to health authorities and clients β€’ Perform and document follow-up activities and manage safety-related queries β€’ Execute quality control checks to ensure data accuracy, completeness, and compliance β€’ Perform reconciliation activities to ensure consistency across safety databases and source documents β€’ Prepare line listings and safety reports as required by projects or clients β€’ Bachelor’s degree in Life Sciences field β€’ Minimum 1 year of experience in pharmacovigilance or safety case processing within the pharmaceutical or CRO industry β€’ Fluency in Mandarin Chinese (Simplified Chinese) and English, with the ability to process pharmacovigilance safety cases originating in Mandarin, is required β€’ Hands-on experience with Argus Safety, Veeva Vault or similar safety databases is preferred β€’ Strong proficiency in MS Office applications β€’ Ability to work independently while managing multiple cases and deadlines β€’ 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 β€’ International team and environment β€’ Remote/home-based position β€’ Monthly bonuses Original job Pharmacovigilance /Case Processing/ Specialist /Mandarin language/ posted on GrabJobs Β©. To flag any issues with this job please use the Report Job button on GrabJobs. Apply tot his job

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