Maintain overall responsibility for the coordination of safety reporting requirements, as required for Marketing Authorization holders (MAH).
- Manage and maintain active involvement in day-to-day individual case safety reports (ICSRs) reporting.
- Key responsibilities include collection, review and reporting of individual case safety reports (ICSRs) and ICSRs combined with product quality complaints (ICSRs+PQCs), obtained through the following sources: spontaneous, solicited, clinical trials, related research activities, local Competent Authorities and all other potential sources, to local Competent Authorities and Global Medical Safety/Office of Consumer Medical Safety, according to local regulations and company procedure documents.
- Detect and report AEs from Local Scientific Literature.
- Track AE cases and perform case follow-ups as needed.
- Undertake follow-up/investigation of local cases of special interest, e.g., fatal case, cluster ADEs, etc., as appropriate.
- Conduct initial quality review and assessment of local individual cases.
- Perform regular reconciliation activities as required by company procedures and local regulations.
- Ensure an effective system in place for 24-hour coverage.
- Ensure to report Foreign SAE reports of import drugs and SUA reports of global clinical trials to health authorities in compliance with China regulations.
- Ensure to report PSUR to health authorities in compliance with China regulations.
- Ensure implementation and compliance with global, regional and local procedural documents applicable to Pharmacovigilance.
- Accountable internally for ensuring that the Local Operating Company meets procedurally defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports.
• Other responsibilities.
- Management and support of PV professionals (if appropriate).
- Check and ensure the proper filing of the drug safety reports according to the company file management and retention policies.
- Ensure local procedure documents maintain and update (if appropriate).
- Provide specific ICSR processing training if appropriate.
A. Education/training background:
• Bachelor or higher education of medicine/pharmacology.
• Medical and pharmaceutical knowledge;
• Good at English in listening, speaking, reading and writing;
• Good computer application skills.
C. Work experiences:
• two years’ experience of drug safety in international pharmaceutical companies
• Good capability of communication, cooperation and teamwork.
• Ability of continuous learning to improve comprehensive qualities.
• Fluent spoken and written English,(Above TOEIC 800 or IELTS 6.5)