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A complete spectrum of Clinical Research, Regulatory Affairs, Pharmacovigilance and Medical Information solutions.
Pharmacovigilance Specialist (Case Processing)
Location
Europe + 1 moreAll locations: Europe | Asia
Posted
25 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Pharmacovigilance Specialist (Case Processing)
Biomapas
Role Description Biomapas & Delta PV is looking for a Pharmacovigilance (Case Processing) Specialist with Mandarin language. The 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. - 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 Requirements - 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 - International team and environment - Remote/home-based position
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