# Pharmacovigilance Specialist (Case Processing / Mandarin language)

**Company:** [Biomapas](http://jobs.workable.com/companies/8iejh2fCgUzZGK2eUKBree.md)
**Location:** Remote
**Workplace:** remote
**Employment type:** Full-time

[Apply for this job](http://jobs.workable.com/view/ff0b3a83-9f3e-42fd-911b-2292dd085902)

## 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:**

-   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

## 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**, 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