上海招聘药物警戒专员

药物警戒专员

Support line manager to validate Chinese translation of safety related documents of Clinical Trial Application & New Drug Application submission dossier as follows:
Safety Report including but not limited to PBRER, RMP, and ethnic comparison on safety data, etc.
Clinical data including clinical safety summary and clinical overview.
Validate Chinese translation of DSUR.
Write local PSUR under the supervision of line manager.
Writer ad-hoc report per regulation under the supervision of line manager.
Support line Manager to review and update local procedures, if required, to ensure they reflect current local and global procedures and regulations.
Support reconciliation for MR/PSP/Digital projects if required.
To ensure all source documents are maintained in accordance with global policy.

致力服务于医药行业。