German-speaking Pharmacovigilance Associate Budapest

German-speaking Pharmacovigilance Associate
Budapest
Budapest, Budapest

• 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.

• University/College degree from Life Sciences, Pharmaceutical or Medical field is a must-have
• Language skills: at least B2 level in German and English
• Previous experience in a similar role or at a pharmaceutical company is an advantage

• Competitive salary 
• Annual bonus
• Risk and accident insurance
• Cafeteria
• Welcoming and open team
• Fitness package
• Home-office (4 day/week)
• Reimbursable language courses
• Fast-paced, growing company

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

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