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 communauté Cognizant :
Nous sommes une équipe de professionnels dont les membres s'apprécient et se soutiennent mutuellement. Nos collaborateurs sont les garants d'un lieu de travail dynamique, collaboratif et inclusif où chacun peut s'épanouir.
- Cognizant est une communauté mondiale qui compte plus de 300 000+ collaborateurs dans le monde entier.
- Nous ne nous contentons pas de rêver de façons idéales, nous apportons des améliorations concrêtes
- Nous prenons soin de nos collaborateurs, de nos clients, de notre entreprise, de nos communautés et du climat, en faisant ce qui est juste.
- Nous favorisons un environnement innovant où vous pouvez construire le plan de carrière qui vous convient.
À propos de nous :
Cognizant est l’un des leaders mondiaux des services professionnels. Nous transformons les modèles commerciaux, opérationnels et technologiques de nos clients pour les adapter à l’ère numérique. Notre approche consultative, basée sur une connaissance sectorielle, aide nos clients à concevoir, développer et gérer des entreprises plus innovantes et plus efficaces. Basée aux États-Unis, Cognizant (membre du NASDAQ-100 et l’un des meilleurs employeurs du monde en 2024 selon Forbes) figure régulièrement parmi les entreprises les plus admirées au monde. Découvrez comment Cognizant aide ses clients à garder une longueur d’avance grâce au numérique sur le site www.cognizant.com.
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.
Vous êtes porteur d'un handicap, vous pouvez-nous contacter par courriel [email protected] si vous souhaitez préciser les aménagements nécessaires pour le poste ou les entretiens à venir.
Mentions légales :
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.
Les candidats peuvent être invités à participer à des entretiens en face à face ou par vidéoconférence. En outre, les candidats peuvent être amenés à présenter une carte d'identité valide lors de chaque entretien.