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French 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: French Speaking Pharmacovigilance QC Associate

Company: Cognizant
Location: Budapest, Hungary – 9th District, Mill Park Office Building
Employment Type: Full-time
Work Mode: Hybrid
Working Hours: 40 hours/week, Normal office hours


🌍 About Cognizant

Cognizant is a global professional services company with 300,000+ associates worldwide, transforming clients’ business, operating, and technology models for the digital era. The company fosters an inclusive, collaborative, and innovative workplace.

Learn more at 🔗 www.cognizant.com


🎯 Role Overview

As a French Speaking Pharmacovigilance QC Associate, you will be responsible for quality control of adverse event (AE) cases, ensuring accurate data entry, translation, and compliance with SOPs, ICH guidelines, and regulatory requirements. You will handle French and English safety reports, perform QC checks, and support training and mentorship initiatives.


🧾 Key Responsibilities

Case Processing & Translation

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

  • Translate European Non-English (French) documents to English and update AE forms

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

  • Triage cases for validity and seriousness

  • Conduct duplicate search and book-in initial/follow-up cases

  • Enter mandatory data into Argus Affiliate/Core database

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

  • Anonymize/redact source documents and AE forms as required

  • Complete daily case tracking spreadsheets

Case Review & Follow-Up

  • Handle queries from central processing sites regarding discrepancies in source documents or AE forms

  • Follow up with Country Organization (CO) if 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

  • Ensure timely completion of all tasks within agreed SLAs

Quality Control & Improvement

  • Review translations and AE forms for accuracy, completeness, and medical relevance

  • Ensure scientific rigor and compliance with SOPs

  • Use process guidance documents to confirm all relevant AE terms and safety data are captured correctly

  • Identify missing or incorrect information and facilitate corrections

  • Provide feedback, monitor associate performance, and collaborate with TCBAs

  • Assist with audits, inspections, and knowledge of ICH guidelines

  • Support training and mentorship of new associates


🎓 Qualifications & Skills

  • Graduate/Postgraduate/Doctorate in Life Sciences, Pharmacy, Medical Sciences, or equivalent

  • 1 year experience in Pharmacovigilance or relevant Clinical experience

  • French and English proficiency (B2 CEFR minimum); native non-English speakers should have education in English and French

  • Knowledge of pharmacovigilance processes and ICH guidelines

  • Strong analytical, problem-solving, and communication skills

  • Ability to work in a multicultural, multilingual environment


🌟 Benefits & Perks

  • Competitive salary and cafeteria benefits

  • Medical benefits and risk/accident insurance

  • All You Can Move SportPass (discounted)

  • Training, continuous learning, and certification opportunities

  • Multilingual and multicultural work environment

  • Modern office with easy access from city centre

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

  • Reimbursable language courses


⚖️ Equal Opportunity Employer

Cognizant provides equal employment opportunities and reasonable accommodations upon request: 📧 CareersNA2@cognizant.com


📝 Additional Information

  • Interviews may be in-person or virtual

  • Candidates may need to present government-issued ID during interviews

  • Compensation is subject to change as per applicable law