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Dutch Speaking Pharmacovigilance Qc Associate

1 year years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Hybrid Education: Graduate degree in Pharmacy or 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


Location:

Budapest, Hungary


Job Type:

Full-time


Working Model:

Hybrid


About Cognizant:

Cognizant is a global leader in technology and consulting services, dedicated to helping businesses transform and innovate. We foster 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:

Responsible for translation and quality control (QC) of Adverse Event (AE) reports, data entry and QC of safety data into safety databases, and ensuring timely, high-quality case processing while maintaining audit readiness.


Key Responsibilities:

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

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

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

  • Triage cases for validity and seriousness (if applicable).

  • Perform duplicate searches and book initial or follow-up cases accordingly.

  • Enter mandatory information into Argus Affiliate/Core databases.

  • Conduct self and peer QC of cases before routing to central processing.

  • Anonymize/redact source documents and AE forms as needed.

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

  • Handle queries from central processing sites regarding discrepancies; follow up with Country Organization if necessary.

  • Generate follow-up action items and letters for fatal, serious, pregnancy-related, and non-cases.

  • Transfer cases and documents as per procedures.

  • Complete daily tasks within agreed Service Level Agreements (SLAs).

  • Prioritize cases based on validity and seriousness.

  • Review translations and data entries to ensure medical relevance, completeness, and accuracy per SOPs.

  • Ensure scientific rigor and timely data entry with quality emphasis.

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

  • Identify missing or incorrect clinically relevant information and facilitate correction.

  • Provide feedback, monitor associate performance, and collaborate with TCBAs to improve quality.

  • Identify root causes and suggest corrective/preventive actions.

  • Respond to TCBA queries with adequate feedback.

  • Assist with administrative and procedural tasks as required.

  • Support training, mentorship, audits, and inspections; knowledge of ICH guidelines is essential.


Qualifications:

  • Graduate degree in Pharmacy or Life Sciences.


Skills and Experience:

  • Minimum 1 year of pharmacovigilance or relevant clinical experience.

  • Excellent spoken and written proficiency in Dutch and English.


Equal Opportunity Employer:

Cognizant is an equal opportunity employer that celebrates diversity and fosters an inclusive environment for all employees.


The Cognizant Community:

We are a high-caliber team that supports one another in an energetic, collaborative, and inclusive workplace where everyone can thrive. With over 300,000 associates worldwide, we make a difference by taking care of our people, clients, communities, and the environment.


Additional Information:

  • Compensation is accurate as of the posting date and may be modified subject to 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).