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).
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Athens | Koropi |Greece :
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Auckland |New Zealand :
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Madrid |Cebu Province :
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Manila |Croatia :
Croatia |Zagreb :
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