Job Title:
German 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 and inspiring working atmosphere with multicultural community and state-of-the-art technologies
Easy access 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: Freshers to 2+ years experience in Pharmacovigilance preferred
Language Skills: Good spoken and written English and German proficiency (minimum B2 CEFR or equivalent) or native non-English speaker with education in English and German
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).
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