German speaking Pharmacovigilance Associate
1 month ago
Job location: Budapest, Hungary, 9thDistrict, Mill Park Office Building
Role type: Full time employment
Working hours: 40 hours/ week
Office attendance once a month
Support window: 9:00 – 17:30
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
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 German & English proficiency (level B2 CEFR (Common European Framework of Reference for Languages) minimum or equivalent) or Native German speaker with education in English medium
- Minimal Education Qualification: Graduate in Life Sciences domain
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
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