Our American multinational partner company, which is supporting its clients in different areas, is looking for Dutch speakers, fresh starters as well as experienced Pharma/Life Sciences graduates for their team.

Benefits :

• Competitive salary and cafeteria benefits; free sport allowance (near the office buildings), All You Can Move SportPass (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 building (easy to reach from city centre, 10-15 minute commute)
• 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

Your tasks will be:

• 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.

Requirements:

• Graduate in Pharmacy or Life Science
• 1 year of Pharmacovigilance or relevant clinical experience
• Excellent spoken and written Dutch and English proficiency