Dutch speaking Pharmacovigilance QC Associate
Location: Budapest, Hungary
Job Type: Full-time
About Cognizant: Cognizant is a global leader in technology and consulting services, dedicated to helping businesses transform and innovate. We are committed to fostering a diverse and inclusive workplace where every employee can thrive.
Why Join Us:
- Competitive salary and benefits
- Opportunities for professional growth and development
- Collaborative and innovative work environment
- Commitment to diversity and inclusion
Job Description: The role requires to Translation & Translation QC of Adverse Event Reports and Data Entry and Data Entry QC (if required) of safety data into safety database. This role also required timely completion of assignment of cases/activities, maintaining quality and timelines and ensuring audit readiness.
Key Responsibilities:
§ 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
§ Save the Local language source document and Standard AE form in common drive or folder
§ 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
§ Self / 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 IDs
§ Handling of queries (action items) received from the central processing sites regarding discrepancies in Source Documents, AE form and / or Argus Affiliate / Core database
§ Follow 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 letter
§ Transfer 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 database
§ Transfer the case to Central site / Case processing team
§ Responsible 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 it
§ To 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 / 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
§ Use process guidance documents to check if the relevant adverse event terms and safety data was captured appropriately by the associate in AE Form/safety database
§ Identify 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 / Core
§ Providing feedback, documenting it appropriately, monitoring of associate’s performance and closely working with the TCBAs to improve Quality
§ To identify and analyze root cause, and suggest appropriate corrective and preventive actions as necessary
§ Respond to queries raised by the TCBAs and provide adequate feedback
§ Assist with related administrative and procedural activities as per project requirement
§ Assists in the training and Mentorship of other Case processing related activities as necessary
§ Assists in audits and inspections and must have knowledge of International Conference on Harmonization (ICH)
Qualifications: Graduate in Pharmacy or Life Science
Skills and Experience:
- 1 year of Pharmacovigilance or relevant clinical experience
- Excellent spoken and written Dutch and English proficiency
Equal Opportunity Employer: Cognizant is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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.
- Fomentamos un entorno innovador en el que puedes construir la trayectoria profesional adecuada para ti.
Sobre nosotros:
Cognizant es una de las principales empresas de servicios profesionales del mundo, transformando los modelos comerciales, operativos y tecnológicos de los clientes para la era digital. Nuestro enfoque consultivo único basado en la industria ayuda a los clientes a visualizar, construir y ejecutar negocios más innovadores y eficientes. Con sede en los Estados Unidos, Cognizant (miembro del NASDAQ-100 y uno de los Mejores Empleadores Mundiales de Forbes 2024) figura constantemente entre las empresas más admiradas del mundo. Descubre cómo Cognizant ayuda a los clientes a liderar con lo digital en nuestro sitio
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.
Si tienes una discapacidad que requiere adaptaciones razonables para buscar una vacante de trabajo o enviar una solicitud, puedes enviar un correo electrónico a [email protected] con tu solicitud e información de contacto.
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.