Patient Safety Assistant
1/ Patient safety assistant :
· Get SAE notification from CRC. Create timeline for CRC.
· Tracking SAE/AE of clinical trials then input into excel file.
· Following and tracking AOR.
· Save and scan SAE/AOR.
· Synthesize by quarter all cases of clinical trial which is late .(IBP report ).
· Update all cases which is missing scanned copy and remind CRA (Per 2 weeks).
· Keep tracking on PSLL/PBRER and download when informed by Global , send to the doctor for translating then send to TA/PS Lead for reviewing , get submitted by head of medical , and finally send to Ministry of Health .
· Keep tracking on AOR.
· Keep tracking on payment bill for Doctor who translated the PSLL/PBRER , and renew the contract for them following timeline.
· Input marketed product into Jasper following timeline.
· Input data for “Safety of Brilinta program”.
· Take part in all training the course that related to Patient Safety: Jasper, Angel Cara systems.
2/Medical information assistance:
· Filtering all the questions received from Field Force and send to TA. Transfer to PS if the questions are AE .
· Upload the questions to the system along with the answers following process (Within 5 days from the day received the question)
· Keep reminding TA to get answer for the question within 3 days.
· Take part in all the training related to get access to MI: GMIP, VEEVA systems
3/ IC :
· Reviewing documents received from CME, get submit.
· Create events on E2E and upload all the documents related for submitting.
· After documents was approved, get invitation letter from CME , get submitted by Head of Medical and transfer back to MSL.
· Check with CME to get all the documents that need (signed off invitation letters, abroad working permission), upload into E2E and get submit following timeline.
· Create an excel report of IC each month and reporting back to NS and Head of Medical.
4/ Create an Excel report per week: Update all CV information belong to KEEs per week.