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Portuguese and Spanish speaking QC Pharmacovigilance Associate

44334

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


La comunidad de Cognizant:

Somos un equipo de alto calibre que se aprecia y se apoya mutuamente. Nuestra gente defiende un lugar de trabajo enérgico, colaborativo e inclusivo donde todos puedan prosperar.

  • Cognizant es una comunidad global con más de 300.000 asociados en todo el mundo.
  • No solo soñamos con una mejor manera, sino que la hacemos realidad.
  • Cuidamos a nuestra gente, clientes, empresas, comunidades y el clima haciendo lo correcto.
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Sobre nosotros:
Cognizant (NASDAQ: CTSH) es arquitecto de soluciones de IA y proveedor de servicios tecnológicos que traduce la inversión en inteligencia artificial en valor empresarial real mediante soluciones de IA de stack completo adaptadas a cada cliente. Su profundo conocimiento de la industria, los procesos y la ingeniería le permite integrar el contexto único de cada organización en sistemas tecnológicos que amplifican el potencial humano, generan un impacto real en el negocio y mantienen a las grandes empresas globales un paso adelante en un mundo en constante cambio. Para más información, visita www.cognizant.es o síguenos en @cognizant.

Cognizant es un empleador que ofrece igualdad de oportunidades. Tu solicitud y candidatura no serán consideradas en base a raza, color, sexo, religión, credo, orientación sexual, identidad de género, origen nacional, discapacidad, información genética, embarazo, condición de veterano o cualquier otra característica protegida por las leyes federales, estatales o locales.

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Disclaimer:
La información de compensación es precisa a la fecha de esta publicación. Cognizant se reserva el derecho de modificar esta información en cualquier momento, sujeto a la legislación aplicable. 

Es posible que se requiera que los solicitantes asistan a entrevistas en persona o por videoconferencia. Además, es posible que se requiera que los candidatos presenten su identificación actual emitida por el estado o gobierno durante cada entrevista.

Aunque nuestro sistema permite la postulación en todos los idiomas, el (los) idioma(s) y el (los) nivel(es) de competencia requeridos para el trabajo varían. Sin embargo, se requiere un nivel básico de inglés para fines de comunicación en toda la empresa.

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