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Pharmacovigilance Specialist (Case Processing / Mandarin language)

2 months ago
China, Kazakhstan, United Kingdom, Singapore, Taiwan
Full-time
Junior
Operations Specialist
Operations
Apply Now
Biomapas

Biomapas

Biomapas offers comprehensive solutions in clinical research, regulatory affairs, pharmacovigilance, and medical information, providing essential support throughout the clinical trial process to enhance drug development and ensure compliance.

Biotechnology
251-1K
Founded 2001
View All Jobs 9

Description

  • Manage and process end-to-end safety case reports in compliance with global and local regulatory requirements.
  • Perform triage of incoming safety information, including 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 data entry, including narrative writing and case documentation.
  • Conduct medical assessments for seriousness, causality, and expectedness.
  • 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 a 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 is required.
  • 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.
  • Willingness to work European working hours is welcome for candidates outside the region.

Benefits

  • International team and working environment.
  • Remote/home-based position.
  • Monthly bonuses.

Interested in this position?

Apply directly on the company website

Apply Now

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