Job Location
Budapest, Hungary – 9th District, Mill Park Office Building
⏱ Working Hours
40 hours per week
Normal office hours
Office Attendance
On‑site presence required once per week
OFFER
- Competitive salary and cafeteria benefits; All You Can Move SportPass (at a discounted price), medical benefits and other perks
- Risk and accident insurance
- Chance to be part of a rapidly expanding organization
- Training and continuous learning and certification opportunities
- Multilingual environment, native colleagues
- Pleasant and inspiring working atmosphere with multicultural community and state-of-the-art technologies
- Easy to access location and modern office building (easy to reach from city centre, 10-15 minute commute)
- Reimbursable language courses
- Team events and Company events (cool and youthful parties with team-games)
- High value awards and recognitions, annual bonus for top performers, and annual salary review
REQUIREMENTS
- Experience: 0 to 2 years of Pharmacovigilance or relevant Clinical experience or translation experience in Medical Documents is preferred
- Language Capability: Good spoken and written Portuguese and Spanish proficiency (level B2 CEFR (Common European Framework of Reference for Languages) minimum or equivalent) or Native speaker with education in English medium
- Minimal Education Qualification: Graduate in Life Sciences domain
DESCRIPTION
- Receipt / 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) form
- Anonymization/Redaction (if applicable)
- Perform reconciliation of cases received with number of cases translated and completed
- Audit and Inspection readiness and support (if required)
- Review Translation of Source Documents from European Non-English Language to English in Standard Adverse Event (AE) Form
- Use process guidance documents to check if the relevant adverse event terms and safety data was translated and captured appropriately by the Translation Associate (TA) in Standard AE form
- Identify clinically relevant information missing from the Standard AE Form and facilitate its entry in it
- Providing feedback, monitoring of TA’s performance and closely working with the TAs to improve Quality
- To identify and analyze root cause, and suggest appropriate corrective and preventive actions for quality issues as necessary
- Assists in the training and Mentorship of other TAs and TQCs and also in the case book-in related activities as necessary
- Mailbox management for applicable COs
- Triage of cases for validity and seriousness (if applicable)
- Perform Duplicate Search
- Book-in Initial case / Follow-up to existing case depending upon the duplicate search results
- Data entry of mandatory information into Argus Affiliate / Core database
- Follow up with Country Organization (CO), if required (via queries and action items)
- Responsible for case QC. Review 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 Data Entry team to correct
- To ensure the case booked-in by the Case Receipt and Book-in Associate (CBA) is medically relevant, complete and accurate as per client Standard Operating Procedures and procedures in Argus Affiliate / Core
- Ensure scientific rigor through accurate check of complete and consistent data entry of adverse event reports from source documents with emphasis on timelines and quality
- Providing feedback, monitoring of CBA’s performance and closely working with the CBAs to improve Quality
- Respond to queries raised by the CBAs and provide adequate feedback
- Assists in the training and Mentorship of other Case book-in related activities as necessary
- Assists in audits and inspections and must have knowledge of International Conference on Harmonization (ICH)
- Mailbox management for applicable COs
CogHU103
À propos de Cognizant
Cognizant (NASDAQ : CTSH) est un AI Builder et une entreprise de services numériques (ESN) élaborant des solutions complètes d’IA maximisant les investissements pour des résultats concrets. Sa profonde expertise des métiers, des processus et des technologies lui permet d’intégrer dans les systèmes technologiques le contexte unique de chaque organisation de l’ingénierie à la production à l’échelle. Son objectif : améliorer l’efficacité des équipes, créer de la valeur et permettre aux grandes entreprises de rester performantes dans un monde qui évolue rapidement. Pour en savoir plus : cognizant.ai ou @cognizant.
Renseignments suppplémentaires sur l'emploi
Les informations relatives à la rémunération du poste à pourvoir dépendent de la date de publication de l’offre de poste. Cognizant se réserve le droit de modifier ces informations à tout moment, sous réserve des lois applicables.
Cognizant est un employeur soucieux de l'égalité des chances entre candidats. Votre candidature sera étudiée indépendamment de votre race, couleur, sexe, religion, croyances, orientation sexuelle, identité de genre, origine, handicap, informations génétiques, grossesse, statut d'ancien militaire ou de toute autre critère jugé discriminant par les lois européennes ou françaises.
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