About the job
Join Biomapas & Delta PV as a Pharmacovigilance Specialist (Case Processing) with Mandarin proficiency.
The Pharmacovigilance Specialist is tasked with ensuring the seamless execution of pharmacovigilance activities at the project level. This role is centered on the intake, processing, and reporting of safety cases, emphasizing comprehensive case management rather than translation, which includes medical assessment and adherence to regulatory standards.
Key Responsibilities:
- Oversee and manage the full life cycle of safety case reports, ensuring compliance with both global and local regulatory mandates.
- Evaluate incoming safety information, determining case validity, seriousness, and necessary follow-up actions.
- Review, organize, and archive source documentation in alignment with pharmacovigilance regulations and internal SOPs.
- Conduct data entry into safety databases (SDB), including narrative writing and case documentation.
- Perform medical assessments addressing seriousness, causality, and expectedness evaluations.
- Ensure timely submission of reports to health authorities and clients based on reporting requirements.
- Document follow-up actions and manage safety-related inquiries.
- Implement quality control measures to guarantee data accuracy, completeness, and compliance.
- Conduct reconciliation tasks to maintain consistency between safety databases and source documentation.
- Prepare line listings and safety reports as required by projects or clients.
