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