Pharmacovigilance Specialist
New
B
BiomapasPharmaceuticals
Malaysia. Philippines. Vietnam. Thailand. Hong Kong, Hong Kong, Hong Kong. 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, European working hoursFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- Mandarin Chinese, English
- Experience
- Minimum 1 year
- Required Skills
- MS OfficeData entry
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
- Ability to process pharmacovigilance safety cases originating in Mandarin
- 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
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
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