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 evalua...