Job Title : Drug Safety Associate

Overall Purpose of the Job

Responsible for the processing and evaluation of Serious Adverse Events / Post Marketing

Adverse Events within agreed timeframes and to a high standard of accuracy, in

compliance with client’s, standard operating procedures and global regulatory requirements.

Responsibilities/Authorities

• Major responsibilities: Perform triage including prioritization of cases
• Perform duplicate search in AA
• Create a case (Initial/FU) in AA.
• Update the daily tracking spreadsheet to be exchanged with the Asia CO.
• Enter the mandatory fields in AA
• Upload the Source document in AA
• Receive feedback from the QC associate and make corrections as per feedback (for mentees).
• Make necessary corrections when applicable
• Upload the ESP Source Document Transcription/Translation Quality Control Form in AA following completion of corrections.
• Create follow‐up action item.
• Route the case to Core
• Successfully complete and clear proficiency test in client data base Affiliate.
• Key performance indicators: Ability to learn quickly.
• Number, timeliness and scientific quality of deliverables according to established directives
• Consistent demonstration of company values/behaviours. Ensure that Post Marketing Adverse Events are evaluated accurately and within the required timeframes to meet regulatory requirements

Requirements

Benefits