Dutch speaking Pharmacovigilance QC Associate

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Cognizant Technology Solutions Hungary
Munkavégzés helye

Hibrid • 1095 Budapest, Soroksári út 44.

Egyéb juttatások
- Cafeteria
- Szakmai tréningek
- Nyelvtanulás támogatása
- Egészségbiztosítás
- Sport támogatás
- Élet- és balesetbiztosítás
Munkaidő, foglalkoztatás jellege
- Teljes munkaidő
- Alkalmazotti jogviszony
- Általános munkarend
Biztosított eszközök
- Laptop
- Windows
- Headset
Elvárások
- Angol középfok és
- Holland középfok
- 1-3 év tapasztalat
- Főiskola

Cafeteria Szakmai tréningek Nyelvtanulás támogatása Egészségbiztosítás Sport támogatás Élet- és balesetbiztosítás

Teljes munkaidő Alkalmazotti jogviszony Általános munkarend

Laptop Windows Headset

Angol középfok és Holland középfok 1-3 év tapasztalat Főiskola

Állás elmentve

A hirdetést eltávolítottuk a mentett állásai közül.

A hirdetés adatait sikeresen elküldte az email címére.

About us

Cognizant is one of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build, and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant (a member of the NASDAQ-100 and one of Forbes World’s Best Employers 2024) is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at our website.

Responsibilities:

Receipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)
Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form
Save the Local language source document and Standard AE form in common drive or folder
Triage of cases for validity and seriousness (if applicable)
Perform Duplicate Search
Book-in Initial case / Follow-up to existing case depending upon the duplicate search results
Data entry of mandatory information into Argus Affiliate / Core database
Self / Peer Quality Check (QC) of the cases before routing to central processing (as applicable)
Anonymizing / Redacting Source Documents and / or Adverse Event (AE) Forms (as applicable)
Complete the daily case tracking spreadsheet with Local Affiliate Module (LAM) / Argus IDs
Handling of queries (action items) received from the central processing sites regarding discrepancies in Source Documents, AE form and / or Argus Affiliate / Core database
Follow up with Country Organization (CO), if required (via queries and action items)
Generating Follow-Up Action Items for Fatal, Life-Threatening, Serious & Non-Serious cases and for Pregnancy cases (Serious & Non-Serious) & Non-Cases,
Generate follow-up letter
Transfer the letters & source documents for Patient Safety Information (PSI) book-in activity to CO via Document Exchange Tool (if applicable)
Upload source documents and / or AE form in Argus Affiliate / Core database
Transfer the case to Central site / Case processing team
Responsible for completion of day-to-day work and process flows within agreed Service Level Agreements (SLAs).
Prioritization of cases as per Validity & Seriousness (if applicable)
Anonymizing / Redacting Source Documents and / or Standard Adverse Event (AE) Forms (as applicable)
Responsible for case QC. Review Translation of Source Documents from European Non-English Language to English in Standard Adverse Event (AE) Form and verify data processed in Argus Affiliate (AA) or Argus Core against source documents and AE forms. If error found, revise data or route back to correct it
To ensure the case translated and/or booked-in by the an associate is medically relevant, complete and accurate as per Standard Operating Procedures (SOPs) and procedures in Argus Affiliate / Core
Ensure scientific rigor through accurate check of complete and consistent data entry of adverse event reports from source documents with emphasis on timelines and quality
Use process guidance documents to check if the relevant adverse event terms and safety data was captured appropriately by the associate in AE Form/safety database
Identify clinically relevant information missing or error found in the case then facilitate its entry/correction (by revising or routing back) in AE Form/Argus Affiliate / Core
Providing feedback, documenting it appropriately, monitoring of associate’s performance and closely working with the TCBAs to improve Quality
To identify and analyze root cause, and suggest appropriate corrective and preventive actions as necessary
Respond to queries raised by the TCBAs and provide adequate feedback
Assist with related administrative and procedural activities as per project requirement
Assists in the training and Mentorship of other Case processing related activities as necessary
Assists in audits and inspections and must have knowledge of International Conference on Harmonization (ICH)

Your profile:

Qualifications: Graduate in Pharmacy or Life Science

Skills and Experience:

1 year of Pharmacovigilance or relevant clinical experience
Excellent spoken and written Dutch and English proficiency

We offer:

Competitive salary and benefits
Opportunities for professional growth and development
Collaborative and innovative work environment
Commitment to diversity and inclusion

Work extras

Corporate events
Parking

About Cognizant:

Cognizant is a global leader in technology and consulting services, dedicated to helping businesses transform and innovate. We are committed to fostering a diverse and inclusive workplace where every employee can thrive.