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Pharmacovigilance Associate
1 month ago
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:
- Receive and route safety information to the appropriate department.
- Monitor mailboxes and triage patient safety reports and emails.
- Maintain and archive emails and source documents.
- Enter safety information into the front-end system and assess case validity.
- Perform initial checks, search databases, and ensure upfront clarification requests.
- Enter safety information, evaluate seriousness, and identify discrepancies.
- Translate and back-translate safety information as necessary.
- Responsible for receiving, reviewing, and archiving source data records.
- Identify discrepancies and maintain email clarifications for SDV.
- Perform Health Authority database/registry extraction to retrieve and process Individual Case Safety Reports.
- 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.
