Spanish and Portuguese speaking Pharmacovigilance QC Associate

Job location: Budapest, Hungary, 9thDistrict, Mill Park Office Building Role type: Full time employmentWorking hours: 40 hours/ weekHybrid work modeNormal office hoursOFFERCompetitive salary and cafeteria benefits; All You Can Move SportPass (at a discounted price), medical benefits and other perksRisk and accident insuranceChance to be part of a rapidly expanding organizationTraining and continuous learning and certification opportunitiesMultilingual environment, native colleaguesPleasant and inspiring working atmosphere with multicultural community and state-of-the-art technologiesEasy to access location and modern office building (easy to reach from city centre, 10-15 minute commute)Reimbursable language coursesTeam events and Company events (cool and youthful parties with team-games)High value awards and recognitions, annual bonus for top performers, and annual salary reviewRequirementsMinimal Education Qualification: Graduate/Postgraduate/Doctorate degree in Life sciences/ Pharmacy/Medical sciences or equivalent degreeExperience: Freshers to 2 years plus experience in Pharmacovigilance preferredLanguage Capability: Good spoken and written English, Spanish and Portuguese proficiency (level B2 CEFR (Common European Framework of Reference for Languages) minimum or equivalent) or Native Non-English speaker with education in English and Spanish and Portuguese mediumDescriptionReceipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) formSave the Local language source document and Standard AE form in common drive or folderTriage of cases for validity and seriousness (if applicable)Perform Duplicate SearchBook-in Initial case / Follow-up to existing case depending upon the duplicate search resultsData entry of mandatory information into Argus Affiliate / Core databaseSelf / Peer Quality Check (QC) of the cases before routing to central processing (as applicable)Anonymizing / Redacting Source Documents and / or Adverse Event (AE) Forms (as applicable)Complete the daily case tracking spreadsheet with Local Affiliate Module (LAM) / Argus IDsHandling of queries (action items) received from the central processing sites regarding discrepancies in Source Documents, AE form and / or Argus Affiliate / Core databaseFollow up with Country Organization (CO), if required (via queries and action items)Generating Follow-Up Action Items for Fatal, Life-Threatening, Serious & Non-Serious cases and for Pregnancy cases (Serious & Non-Serious) & Non-Cases,Generate follow-up letterTransfer the letters & source documents for Patient Safety Information (PSI) book-in activity to CO via Document Exchange Tool (if applicable)Upload source documents and / or AE form in Argus Affiliate / Core databaseTransfer the case to Central site / Case processing teamResponsible for completion of day-to-day work and process flows within agreed Service Level Agreements (SLAs).Prioritization of cases as per Validity & Seriousness (if applicable)Anonymizing / Redacting Source Documents and / or Standard Adverse Event (AE) Forms (as applicable)Responsible for case QC. Review Translation of Source Documents from European Non-English Language to English in Standard Adverse Event (AE) Form and verify data processed in Argus Affiliate (AA) or Argus Core against source documents and AE forms. If error found, revise data or route back to correct itTo ensure the case translated and/or booked-in by the an associate is medically relevant, complete and accurate as per Standard Operating Procedures (SOPs) and procedures in Argus Affiliate / CoreEnsure scientific rigor through accurate check of complete and consistent data entry of adverse event reports from source documents with emphasis on timelines and qualityUse process guidance documents to check if the relevant adverse event terms and safety data was captured appropriately by the associate in AE Form/safety databaseIdentify clinically relevant information missing or error found in the case then facilitate its entry/correction (by revising or routing back) in AE Form/Argus Affiliate / CoreProviding feedback, documenting it appropriately, monitoring of associate’s performance and closely working with the TCBAs to improve QualityTo identify and analyze root cause, and suggest appropriate corrective and preventive actions as necessaryRespond to queries raised by the TCBAs and provide adequate feedbackAssist with related administrative and procedural activities as per project requirementAssists in the training and Mentorship of other Case processing related activities as necessaryAssists in audits and inspections and must have knowledge of International Conference on Harmonization (ICH)