Job Title:
Portuguese Speaking Pharmacovigilance QC Associate
Location:
Budapest, Hungary
9th District, Mill Park Office Building
Role Type:
Full-time employment
Working Hours:
40 hours per week
Normal office hours
Hybrid work mode
Job Summary:
Responsible for quality control (QC) activities in pharmacovigilance, including case receipt, data entry, translation of adverse event information from Portuguese and other European languages to English, case triage, duplicate search, and ensuring compliance with regulatory standards and SOPs. The role requires strong Portuguese and English proficiency and involves collaboration across teams to maintain data accuracy and quality.
Key Responsibilities:
Receive, download, and accept cases from Document Exchange Tool or other sources.
Translate relevant European non-English information into English and update Standard Adverse Event (AE) forms accordingly.
Save source documents and AE forms in a common drive or folder.
Triage cases for validity and seriousness, including performing duplicate searches.
Book initial and follow-up cases based on duplicate search results.
Enter mandatory data into Argus Affiliate/Core database.
Conduct self and peer quality checks (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) / Argus IDs.
Handle queries from central processing sites regarding discrepancies and follow up with Country Organization (CO) as necessary.
Generate follow-up action items and letters for various case types (fatal, serious, pregnancy-related, non-cases).
Transfer cases and documents between systems and teams following proper protocols.
Prioritize cases according to validity and seriousness criteria.
Review and verify case translations and data entries for medical relevance, completeness, and accuracy.
Ensure scientific rigor and compliance with SOPs and regulatory requirements, including ICH guidelines.
Identify missing or incorrect clinically relevant information and facilitate correction.
Provide feedback and support to case processing associates to improve quality.
Assist with training, mentorship, audits, and inspections as required.
Participate in continuous improvement initiatives for pharmacovigilance quality processes.
Requirements:
Education: Graduate/Postgraduate/Doctorate degree in Life Sciences, Pharmacy, Medical Sciences, or equivalent.
Experience: Freshers to 2+ years of pharmacovigilance experience preferred.
Languages:
Proficiency in spoken and written English and Portuguese (minimum B2 CEFR level or equivalent).
Native non-English speakers must have education in English and Portuguese medium.
Strong attention to detail and analytical skills.
Ability to work effectively in a hybrid work environment.
Familiarity with pharmacovigilance databases (e.g., Argus Affiliate/Core).
Knowledge of International Conference on Harmonization (ICH) guidelines is a plus.
Offer:
Competitive salary and cafeteria benefits
All You Can Move SportPass at discounted price
Medical benefits and other perks
Risk and accident insurance
Opportunity to join a rapidly expanding organization
Training, continuous learning, and certification opportunities
Multilingual and multicultural working environment
Pleasant and inspiring workplace with state-of-the-art technologies
Easy access location with 10-15 minutes commute from city center
Reimbursable language courses
Team and company events (youthful parties, team games)
High value awards, recognitions, annual bonus for top performers, and salary reviews
About Cognizant:
Cognizant is a leading global professional services company that helps clients transform business and technology models for the digital era. With over 300,000 associates worldwide, Cognizant fosters an inclusive and collaborative environment that promotes career growth and innovation.
Learn more at www.cognizant.com
Equal Opportunity Employer:
Cognizant is committed to diversity and inclusion. Applications are considered without regard to race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status, or other protected characteristics.
Accessibility Accommodation:
If you need reasonable accommodation during the application process due to a disability, please contact:
📧 CareersNA2@cognizant.com
Additional Notes:
Compensation information is accurate as of the posting date and subject to change.
Candidates may be required to attend interviews in person or via video conference.
Presentation of valid government-issued ID may be required during interviews.
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