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German Speaking Pharmacovigilance Qc Associate (Maternity Cover)

Freshers to 2+ years years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Hybrid Education: Graduate / Postgraduate / Doctorate degree in Life Sciences, Pharmacy, Medical Sciences, or a related field 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:

German Speaking Pharmacovigilance QC Associate (Maternity Cover)
Job ID: JD 3


Location:

Budapest, Hungary
9th District, Mill Park Office Building


Employment Type:

  • Full-time

  • Maternity cover contract

  • 40 hours/week

  • Hybrid work mode

  • Standard office hours


What We Offer:

  • Competitive salary and cafeteria benefits

  • Annual bonus for top performers

  • Annual salary review

  • Risk and accident insurance

  • Medical benefits package

  • Discounted All You Can Move SportPass

  • Reimbursable language courses

  • Continuous learning and certification opportunities

  • High-value awards and recognitions

  • Pleasant, multicultural work environment with state-of-the-art technologies

  • Multilingual team with native colleagues

  • Modern, centrally located office (10–15 min from city center)

  • Team events and youthful company parties with team games

  • Opportunity to be part of a rapidly expanding global organization


Required Qualifications:

Education:

  • Graduate / Postgraduate / Doctorate degree in Life Sciences, Pharmacy, Medical Sciences, or a related field

Experience:

  • Freshers to 2+ years of experience in Pharmacovigilance preferred

Languages:

  • Proficiency in German and English

  • Minimum B2 level (CEFR) in both written and spoken communication

  • OR native non-English speaker with education in English and German medium


Key Responsibilities:

  • Receive and download safety cases via Document Exchange Tool or other sources

  • Translate relevant European non-English source documents to English (if needed)

  • Update relevant fields in the Standard Adverse Event (AE) Form

  • Save source documents and AE forms in designated shared folders

  • Triage cases for validity and seriousness

  • Perform duplicate searches and book in cases (initial or follow-up) accordingly

  • Enter mandatory case data into Argus Affiliate/Core database

  • Perform Self or Peer Quality Check (QC) before case transfer to central processing

  • Anonymize or redact AE forms and source documents when necessary

  • Maintain and update daily case tracking spreadsheet (LAM / Argus IDs)

  • Handle discrepancies and queries from central processing sites

  • Follow up with Country Organization (CO) on data issues

  • Generate follow-up action items for:

    • Fatal, Life-Threatening, Serious & Non-Serious cases

    • Pregnancy cases (Serious & Non-Serious)

    • Non-cases

  • Draft and transfer follow-up letters and source documents for PSI book-in activity

  • Upload source documents and AE forms to Argus database

  • Transfer complete cases to Central Site / Case Processing Team

  • Ensure completion of work within Service Level Agreements (SLAs)

  • Prioritize cases based on validity and seriousness


Quality Control Responsibilities:

  • Ensure data and translations are accurate, complete, and scientifically valid

  • Verify data in AE forms and Argus against original source documents

  • Use process guidance to confirm correct capture of adverse events and safety data

  • Identify and correct any errors or omissions in the AE form or Argus database

  • Provide constructive feedback to team members and support performance improvement

  • Monitor associate performance and document findings appropriately

  • Collaborate with Team Case Book-in Associates (TCBAs) to enhance overall quality

  • Conduct root cause analysis and propose corrective/preventive actions

  • Respond to quality queries raised by team members or central reviewers

  • Assist with administrative tasks, audits, and procedural compliance

  • Support the training and mentoring of new or junior team members

  • Maintain awareness and compliance with ICH (International Conference on Harmonization) guidelines


About Cognizant:

Cognizant is a leading global professional services company, transforming clients' business, operating, and technology models for the digital era.

  • 300,000+ associates worldwide

  • Member of NASDAQ-100

  • Recognized among Forbes World’s Best Employers 2024

Visit us at: www.cognizant.com


Diversity and Inclusion:

Cognizant is an equal opportunity employer. We do not discriminate on the basis of:

  • Race, color, religion, sex, sexual orientation, gender identity

  • National origin, disability, genetic information, pregnancy, or veteran status

If you require reasonable accommodation for the application process, please contact:
📧 CareersNA2@cognizant.com


Additional Information:

  • Compensation data is accurate as of this posting and subject to change

  • Interviews may be held in-person or virtually

  • ID verification may be required during interviews