Portugese and Spanish speaking Pharmacovigilance Associate (Maternity cover)

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Cognizant Technology Solutions Hungary Kft.
Munkavégzés helye

Budapest
Egyéb juttatások
- Cafeteria
- Sport támogatás
- Élet- és balesetbiztosítás
Munka típusa
- Teljes munkaidő
- Alkalmazotti jogviszony
Elvárások
- Angol felsőfok és
- Spanyol középfok és
- Portugál középfok
- Nem kell tapasztalat
- Főiskola

Cafeteria Sport támogatás Élet- és balesetbiztosítás

Teljes munkaidő Alkalmazotti jogviszony

Angol felsőfok és Spanyol középfok és Portugál középfok Nem kell tapasztalat Főiskola

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Cognizant Technology Solutions Hungary Kft.

Portugese and Spanish speaking Pharmacovigilance Associate (Maternity cover)

OFFER

Competitive salary and cafeteria benefits; All You Can Move SportPass (at a discounted price), medical benefits and other perks
Risk and accident insurance
Chance to be part of a rapidly expanding organization
Training and continuous learning and certification opportunities
Multilingual environment, native colleagues
Pleasant and inspiring working atmosphere with multicultural community and state-of-the-art technologies
Easy to access location and modern office building (easy to reach from city centre, 10-15 minute commute)
Reimbursable language courses
Team events and Company events (cool and youthful parties with team-games)
High value awards and recognitions, annual bonus for top performers, and annual salary review

DESCRIPTION

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
Anonymization/Redaction (if applicable)
Perform reconciliation of cases received with number of cases translated and completed
Audit and Inspection readiness and support (if required)
Review Translation of Source Documents from European Non-English Language to English in Standard Adverse Event (AE) Form
Use process guidance documents to check if the relevant adverse event terms and safety data was translated and captured appropriately by the Translation Associate (TA) in Standard AE form
Identify clinically relevant information missing from the Standard AE Form and facilitate its entry in it
Providing feedback, monitoring of TA’s performance and closely working with the TAs to improve Quality
To identify and analyze root cause, and suggest appropriate corrective and preventive actions for quality issues as necessary
Assists in the training and Mentorship of other TAs and TQCs and also in the case book-in related activities as necessary
Mailbox management for applicable COs
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
Follow up with Country Organization (CO), if required (via queries and action items)
Responsible for case QC. Review 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 Data Entry team to correct
To ensure the case booked-in by the Case Receipt and Book-in Associate (CBA) is medically relevant, complete and accurate as per client Standard Operating Procedures 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
Providing feedback, monitoring of CBA’s performance and closely working with the CBAs to improve Quality
Respond to queries raised by the CBAs and provide adequate feedback
Assists in the training and Mentorship of other Case book-in related activities as necessary
Assists in audits and inspections and must have knowledge of International Conference on Harmonization (ICH)
Mailbox management for applicable COs

REQUIREMENTS

Experience: 0 to 2 years of Pharmacovigilance or relevant Clinical experience or translation experience in Medical Documents is preferred
Language Capability: Good spoken and written Portuguese and Spanish proficiency (level B2 CEFR (Common European Framework of Reference for Languages) minimum or equivalent) or Native speaker with education in English medium
Minimal Education Qualification: Graduate in Life Sciences domain