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Dutch Speaking Pharmacovigilance Qc Associate

1+ years
Not Disclosed
10 Oct. 1, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

💊 Job Title: Dutch Speaking Pharmacovigilance QC Associate

Company: Cognizant
Location: Budapest, Hungary – BU-Soroksari ut 44
Employment Type: Full-time
Work Mode: Hybrid
Working Hours: 40 hours/week, Normal office hours
Job Number: 45762
Travel Required: No
Job Category: IT Infrastructure


🌍 About Cognizant

Cognizant is a global leader in technology and consulting services, dedicated to helping businesses transform and innovate. The company fosters a diverse, inclusive, and collaborative workplace where every employee can thrive.

Learn more at 🔗 www.cognizant.com


🎯 Role Overview

As a Dutch Speaking Pharmacovigilance QC Associate, you will be responsible for translation, data entry, and quality control of Adverse Event (AE) reports. You will ensure timely case processing, maintain quality standards, and audit readiness, working with Dutch and English safety reports.


🧾 Key Responsibilities

Case Processing & Translation

  • Receive, download, and accept cases from Document Exchange Tool or other sources

  • Translate European Non-English (Dutch) source documents to English, if required

  • Update relevant fields in Standard Adverse Event (AE) forms

  • Save local language source documents and AE forms in shared folders

  • Triage cases for validity and seriousness

  • Perform duplicate searches

  • Book-in initial/follow-up cases depending on duplicate search results

  • Data entry of mandatory information into Argus Affiliate/Core database

  • Perform self/peer QC before routing cases to central processing

  • Anonymize/redact source documents and AE forms

  • Maintain daily case tracking spreadsheet

Case Review & Follow-Up

  • Handle queries/action items regarding discrepancies in source documents, AE forms, or Argus database

  • Follow up with Country Organization (CO) when required

  • Generate follow-up action items for fatal, life-threatening, serious, non-serious, pregnancy, and non-cases

  • Generate follow-up letters and transfer cases/documents for Patient Safety Information (PSI) book-in activity

  • Transfer cases to central site/case processing team

  • Prioritize cases based on validity and seriousness

  • Ensure scientific rigor and complete, accurate, and medically relevant case processing

  • Facilitate corrections for missing or incorrect information

Quality Control & Process Improvement

  • Review translations and AE forms for accuracy, completeness, and compliance with SOPs

  • Provide feedback, document it, and monitor associate performance

  • Collaborate with TCBAs to improve quality and processes

  • Assist in training and mentorship of other associates

  • Support audits and inspections; must be familiar with ICH guidelines


🎓 Qualifications & Skills

  • Graduate in Pharmacy or Life Sciences

  • 1 year of Pharmacovigilance or relevant clinical experience

  • Excellent spoken and written Dutch and English proficiency

  • Knowledge of pharmacovigilance processes and AE reporting

  • Strong analytical, problem-solving, and communication skills

  • Ability to work in a multicultural, multilingual environment


🌟 Benefits & Perks

  • Competitive salary and benefits

  • Medical benefits and risk/accident insurance

  • Training, continuous learning, and certification opportunities

  • Multilingual and multicultural work environment

  • Modern office with easy access from city centre

  • Team and company events, annual bonus, and salary review


⚖️ Equal Opportunity Employer

Cognizant is committed to diversity and inclusion. Reasonable accommodations are available upon request: 📧 CareersNA2@cognizant.com


📝 Additional Information

  • Interviews may be in-person or virtual

  • Candidates may need to present government-issued ID

  • Compensation is accurate as of posting date and subject to change