Start date: latest in September 2018 (or earlier)
Office Location: Nordic Light Budapest, Váci út 96-98, 1133 Magyarország
We are looking for 4 new Spanish speaking associates to join our Affiliate Pharmacovigilance QC team in Budapest.
The Affiliate Pharmacovigilance QC associate is responsible for quality reviewing the entry of source document information in client database done by Affiliate Pharmacovigilance associate, document the feedback in a quality tracker and maintain the quality data for each case. Also, to analyze common defect and defect trend to maintain the appropriate quality. Elevate the common defects to training team and leads.
Route information/safety reports to appropriate Department viz. Medical inquiry (MI), Product complaint (PC), Other inquiry (OI)
Monitoring mailbox, triage for patient safety reports and emails.
Maintaining and archival of emails/source documents and updating sharePoint/folder.
Handling of source document and entering data in client tracking system as per triage criteria. Acknowledge receipt of information as defined by client.
Obtain consent from reporter for follow up report.
Assess cases for missing information and initiate Follow up Query Letter using the proper letter format and tracking the follow up attempts till the closure of follow up.
Check Case Validity as defined by client.
Perform initial checks, search database to prevent duplicate entries.
Ensure that upfront clarification requested in case of data discrepancy in source document.
Enter safety information in client system and evaluating the safety information for case seriousness and potential upgrade and downgrade for seriousness in follow up cases, evaluate dechallenge-rechallenge.
Patient Support Program – Source Data Verification; obtain reports from vendor and reconcile data with client application.
Available after-hours to support the project for operational coverage.
Translation & Back Translation of patient safety reports within the client SLA.
You are a graduate in LifeSciences
You have min 10 months of Pharmacovigilance or relevant Clinical experience
Both English and Spanish language knowledge is a must have (written and oral)
To apply please send your CV to Noemi.Fenyvesi@cognizant.comHelp or apply on the career site.
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