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French Speaking Pharmacovigilance Qc Associate

1 year years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Hybrid Education: Graduate/Postgraduate/Doctorate degree in Life Sciences, Pharmacy, Medical Sciences, or equivalent 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


Location:

Budapest, Hungary
9th District, Mill Park Office Building


Role Type:

Full-time Employment


Working Hours:

40 hours per week
Hybrid Work Mode
Normal Office Hours


Offer:

  • Competitive salary and cafeteria benefits

  • All You Can Move SportPass (discounted price)

  • Medical benefits and other perks

  • Risk and accident insurance

  • Opportunity to be part of a rapidly expanding organization

  • Training, continuous learning, and certification opportunities

  • Multilingual environment with native colleagues

  • Pleasant, inspiring working atmosphere with a multicultural community and state-of-the-art technologies

  • Easy access to location; modern office building (10-15 min commute from city center)

  • Reimbursable language courses

  • Team and company events (youthful parties with team games)

  • High-value awards and recognitions, annual bonus for top performers, and annual salary review


Requirements:

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

  • Experience: Minimum 1 year experience in Pharmacovigilance or relevant clinical experience

  • Language Skills: Good spoken and written English and French proficiency (minimum B2 CEFR or equivalent) or native non-English speaker with education in English and French


Job Description & Key Responsibilities:

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

  • Translate relevant European non-English source documents into English (if required) and update Standard Adverse Event (AE) forms accordingly

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

  • Triage cases for validity and seriousness (if applicable)

  • Perform duplicate case searches

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

  • Enter mandatory information into Argus Affiliate/Core database

  • Conduct self and peer Quality Checks (QC) of cases before routing to central processing

  • Anonymize/redact source documents and/or AE forms as applicable

  • Complete daily case tracking spreadsheets with Local Affiliate Module (LAM) and Argus IDs

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

  • Follow up with Country Organization (CO) as needed via queries and action items

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

  • Generate follow-up letters

  • Transfer letters and source documents for Patient Safety Information (PSI) book-in activities to CO via Document Exchange Tool (if applicable)

  • Upload source documents and/or AE forms into Argus Affiliate/Core database

  • Transfer cases to central site or case processing teams

  • Complete daily work and process flows within agreed Service Level Agreements (SLAs)

  • Prioritize cases based on validity and seriousness

  • Perform case QC by reviewing translations and verifying data accuracy against source documents and AE forms

  • Ensure medical relevance, completeness, and accuracy per SOPs and Argus procedures

  • Ensure scientific rigor through accurate, consistent data entry with emphasis on quality and timelines

  • Use guidance documents to verify correct capture of adverse event terms and safety data

  • Identify and facilitate correction of clinically relevant missing or erroneous information

  • Provide feedback, monitor associates’ performance, and collaborate with TCBAs to improve quality

  • Identify root causes and recommend corrective and preventive actions

  • Respond to queries raised by TCBAs and provide adequate feedback

  • Assist with related administrative and procedural tasks as required

  • Assist in training and mentoring of other case processing associates

  • Assist in audits and inspections; possess knowledge of International Conference on Harmonization (ICH) guidelines


About Cognizant:

Cognizant is a leading global professional services company, transforming clients' business, operating, and technology models for the digital era. Headquartered in the U.S., and a NASDAQ-100 member, Cognizant is consistently ranked among the most admired companies worldwide. Learn more at www.cognizant.com.


Equal Opportunity Employer:

Cognizant celebrates diversity and is committed to creating an inclusive environment. Applications will be considered regardless of race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status, or other protected characteristics.


Additional Information:

  • Compensation details are accurate as of the posting date and subject to change per applicable law.

  • Candidates may be required to attend interviews in person or via video conference and present valid government-issued ID.

  • Reasonable accommodations are available for applicants with disabilities (contact CareersNA2@cognizant.com).