Pharmacovigilance QC Associate - French speaker
Employer · Cognizant
Other health professional
Medical records technician
TranslatorFull-timeBudapest
For our Budapest center, Hungary, we are looking for experienced Pharmacovigilance Associates with advanced French language skills.
Tasks
- 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)
Conditions & benefits
Competitive salary and cafeteria benefits; All You Can Move Sport pass, Medical benefits and other perksRisk and accident insuranceTraining and continuous learning and certification opportunitiesReimbursable language courses
Requirements
- 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
- Effective Communication skills
- Performing tasks accurately and in timely manner
- Result Oriented