Pharmacovigilance Associate

About the Role:

As a Pharmacovigilance Associate, you will play a crucial role in ensuring the safety of patients by monitoring and managing adverse event reports.

Key Responsibilities:

1. Receive and route safety information to the appropriate department.
2. Monitor mailboxes and triage patient safety reports and emails.
3. Maintain and archive emails and source documents.
4. Enter safety information into the front-end system and assess case validity.
5. Perform initial checks, search databases, and ensure upfront clarification requests.
6. Enter safety information, evaluate seriousness, and identify discrepancies.
7. Translate and back-translate safety information as necessary.
8. Responsible for receiving, reviewing, and archiving source data records.
9. Identify discrepancies and maintain email clarifications for SDV.
10. Perform Health Authority database/registry extraction to retrieve and process Individual Case Safety Reports.
11. Document review processes and work with project quality roles to improve case quality.

Requirements:

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