Dutch speaking Affiliate Pharmacovigilance Associate

2 months ago

Budapest, Hungary Cognizant Technology Solutions Hungary Kft. Full time
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  • Responsible for receiving/downloading information from different channels and receiving voice calls for reporting safety information.
  • Route information/safety reports to appropriate Department (e.g. Medical information, quality assurance) as applicable.
  • Monitoring mailbox, triage for patient safety reports and emails.
  • Maintaining and archival of emails/source documents and updating shared folders.
  • Handling of source document and entering data in front-end system as per triage criteria; acknowledge receipt of information.
  • Obtain consent from reporter to follow up on safety reports.
  • Assess cases for missing information and follow up attempts until closure.
  • Check case validity.
  • Perform initial checks, search database to prevent duplicate entries.
  • Ensure upfront clarification requests in case of data discrepancy identified in source document.
  • Enter safety information in front-end system and evaluating the safety information for case seriousness and potential upgrade and downgrade for seriousness in follow up cases, evaluate dechallenge-rechallenge.
  • Translation & Back Translation of safety information as applicable.
  • Responsible for receiving, reviewing and archiving source data records for any missing/discrepant safety information.
  • Identify discrepancies and maintain email clarifications of discrepancies for SDV.
  • Perform Health Authority database/registry extraction to retrieve and processes Individual Case Safety Reports.
  • Document review processes.
  • Responsible for completion of day-to-day work and process flows within the agreed SLAs
  • Maintaining data as per customer guidelines.
  • Work with project quality roles to improve case quality.
  • Attend training sessions and develop skills and capabilities on an ongoing basis.
  • Timely completion of assigned trainings and training files.
  • Co-ordinate with internal teams to obtain necessary information required for day-to-day operations.
  • Assists in the training and mentorship of new joiners as necessary.
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  • Graduate in Pharmacy or Life Science
  • 1 year of Pharmacovigilance or relevant clinical experience
  • Excellent spoken and written Dutch and English proficiency
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  • Competitive salary and benefit package (cafeteria + annual bonus)
  • Risk and accident insurance 
  • Free medical benefit package
  • Reimbursable language courses
  • All You Can Move SportPass (at a discounted price)
  • Training and continuous learning and certification opportunities
  • Chance to be part of a rapidly expanding organization
  • Multilingual, multicultural environment with native colleagues
  • Team and company events
  • High value awards and recognitions
  • Hybrid work mode: attending the office once per week

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