Pharmacovigilance QC Associates with French/German/Italian/Dutch/Spanish/Portuguese/Russian/Czech/Slovak/Hungarian
Location: Budapest, Hungary
Employment type: full-time (40 hours per week)
Work model: hybrid
For our Budapest center, Hungary, we are looking for experienced Pharmacovigilance Associates with multilingual skills.
We offer:
Competitive salary and cafeteria benefits; All You Can Move Sport pass (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 buildings (easy to reach from city center)
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
Responsibilities:
Receipt / Download / Accept cases from Document Exchange Tool or electronically
Translation of all relevant European Non-English information from source documents to English and updating relevant fields in Standard Adverse Event form
Book-in Initial case / Follow-up to existing case depending upon the duplicate search results
Handling of queries (action items) received from the central processing sites regarding discrepancies in Source Documents
Transfer the letters & source documents for Patient Safety Information (PSI) book-in activity
Upload source documents
Responsible for completion of day-to-day work and process flows within agreed Service Level Agreements (SLAs)
Responsible for case QC. Review Translation of Source Documents from European Non-English Language to English
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
Assists 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)
Required skills:
Graduate / Postgraduate / Doctorate degree in Life sciences / Science / Health care / Pharmacy / Medical sciences or equivalent degree
1 year experience in Pharmacovigilance or relevant Clinical experience
- Fluency in English + French/German/Italian/Dutch/Spanish/Portuguese/Russian/Czech/Slovak/Hungarian
Effective Communication skills
Performing tasks accurately and in timely manner
Result Oriented
CogHU103
コグニザントについて
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雇用に関する追加情報
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