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
Over Cognizant
Cognizant (NASDAQ: CTSH) is een bouwer van AI-oplossingen en een leverancier van technologiediensten. Wij slaan de brug tussen AI-investeringen en ondernemingswaarde door het bouwen van full-stack AI-oplossingen voor onze klanten. Onze diepgaande kennis van sectoren, processen en engineering stelt ons in staat om de unieke context van een organisatie te verankeren in technologische systemen. Deze systemen versterken het menselijk potentieel, realiseren tastbare resultaten en geven wereldwijde ondernemingen een voorsprong in een snel veranderende wereld. Ontdek hoe op cognizant.ai of @cognizant.
Aanvullende arbeidsinformatie
De informatie over de beloning is correct op de datum van deze vacature. Cognizant behoudt zich het recht voor om deze informatie op elk moment te wijzigen, met inachtneming van de toepasselijke wetgeving.
Van sollicitanten kan worden verwacht dat zij gesprekken bijwonen, persoonlijk of via een videogesprek. Daarnaast kan van kandidaten worden gevraagd om tijdens elk gesprek een geldig, door de overheid uitgegeven identiteitsbewijs (zoals een identiteitskaart of paspoort) te tonen.
Cognizant is een werkgever die gelijke kansen biedt. Je sollicitatie en kandidatuur worden niet beoordeeld op basis van ras, huidskleur, geslacht, religie, levensovertuiging, seksuele geaardheid, genderidentiteit, nationale afkomst, handicap, genetische informatie, zwangerschap, veteranenstatus of enige andere eigenschap die wordt beschermd door federale, regionale of lokale wetgeving.
