Pharmacovigilance Case Processing Analyst with French

Job description

Overall Purpose of the job
Responsible for the processing and evaluation of Adverse Events / Post Marketing Adverse Events within agreed timeframes and to a high standard of accuracy, in compliance with Novartis CMO&PS business rules, standard operating procedures and global regulatory requirements as documented in Customer's SOPs.

Responsibilities/Authorities

• Perform safety case processing in accordance with SOP and regulations of client.
• Data entry of cases into Argus system.
• Perform prioritization of cases
• Perform duplicate search in AA
• Open a case (Initial/FU) in AA.
• Update the daily tracking spreadsheet to be exchanged with the France CO.
• Enter the mandatory fields in AA
• Upload the Source document in AA
• Receive feedback form 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.
• Trigger follow-up action item.
• Route the case to Argus Core

Desired profile

Qualifications :

Educational and Experience Requirements:

• Bachelor's Degree, Life Science preferred.
• 0-1 year of Pharmacovigilance or relevant Clinical Experience.
• Good English and French language proficiency (read, write, listen and speak).
• Good knowledge of medical terminology is preferred.
• Ability to enter large quantities of data with high degree of quality.
• Good typing speed.