Job Description

German Speaking Pharmacovigilance Associate Location: Budapest, Hungary Job level: professional Job type: permanent We are looking for a German speaking pharmacovigilance associate 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.   Responsibilities: - 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. Your profile: - Both English (written and spoken) combined with German (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 What we offer: - Competitive salary + Annual bonus system + Cafeteria package - Remote work option - Free medical services - Company insurance - Online trainings - Language course reimbursement - All You can Move Sportpass + other discount fitness options - Easy to access location and fancy, modern office building in Budapest  To apply please send your CV to Noemi.Fenyvesi@cognizant.com