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French speaking Pharmacovigilance Associate

Lokasyon: BUDAPEST, HUNGARY Maaş: Salary Negotiable
İş Alanı: Other Pozisyon Türü: Daimi
Vardiya: N/A Başvurular: 2
Yayınlandı: 2 ay önce Referans numarası: X3-553136

Our multinational partner company is looking for a Pharmacovigilance Associate who 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.

Why it is a good opportunity for you:
• Competitive salary package + Annual bonus system + Cafeteria package
• In-house trainings
• Company insurance
• Language course reimbursement
• Free medical services
• All You can Move Sport pass + other discount fitness options
• Home office option from Hungary

What you will be doing:
• 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 challenge
• 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

Requirements that make you the best candidate:
• Both English (written and spoken) combined with French (written) language knowledge is a must have on minimum B2 level
• Degree in Life Sciences (bachelors or masters) is a MUST, please only apply if you have a finished diploma