Job 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 docum...