Dutch speaking health administrator (PE-12057)
· 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.
What you need to have:
· Graduate in Pharmacy or Life Science
· 1 year of Pharmacovigilance or relevant clinical experience
· Excellent spoken and written Dutch and English proficiency
What we offer:
· Competitive salary and benefit package (cafeteria + annual bonus)
· Training and continuous learning and certification opportunities
· Chance to be part of a rapidly expanding organization
· Multilingual, multicultural environment with native colleagues
· All You Can Move SportPass (at a discounted price)
· Free medical benefit package
· Reimbursable language courses
· Team events, company events
· Relocation package
· High value awards and recognitions