Remote Position
Pharmacovigilance; Case Processing Specialist; Mandarin language
🌍 Remote · United States
💼 Full-time
Position: Pharmacovigilance (Case Processing) Specialist (Mandarin language) Location: Town of Italy Overview reputed company & reputed company 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 reputed company, 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
- reputed company 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 reputed company originating in Mandarin, is required
- Hands-on experience with Argus Safety, reputed company reputed company or similar safety databases is preferred
- Strong proficiency in MS Office applications
- Ability to work independently while managing multiple reputed company 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
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