杭州招聘

Main Responsibilities:
- AE/SAE Processing
? To collect, process and follow up all local adverse events (AEs)/ serious adverse events (SAEs) from different sources
? To report the AE/SAE to the HA according to the Chinese regulation within the required timeframe;
? To log in cases into the local tracking system and transmit all reports to the GPV organization within the required timeframe;
? To archive all source documentation in accordance with Quality Control;
? To file all Pharmacovigilance source documents and keep them available on request by the HA.
- Studies Activities
? To keep updated a table summarizing all clinical trials/ observational studies on-going in the countries, following information provided by the country for the local projects and information provided by GPV for others;
? To submit the Serious Adverse Events, unexpected events to HA according to the national regulations.
- CIOMS Form Collecting
? To maintain the Oracle AERS data base;
? To collect CIOMS form from GPV within the required timeframe.
- Line Listing Submission
? To collect monthly line listing from GPV;
? To reconsolidate the line listing between English version and Chinese version;- To submit the approved Chinese version to HA
- PSURs
? To prepare the local annual AE summary, and send it to the HA according to the pharmacovigilance regulatory requirements;
? To submit individual PSURs released by the GPV to HA;
- Document Archiving
? To maintain the signed train record archiving;
? To maintain the hardcopy of package insert archiving;
? To archive the AE/SAE forms and receipt of GPV

浙江天元生物药业有限公司 诚聘