A XeVMPD (Extended EudraVigilance Medicinal Product Dictionary) Associate specializes in managing and maintaining drug safety data in the European Medicines Agency’s EudraVigilance database.
Job Description of a XeVMPD Associate:
- Data Management: Responsible for entering and updating information about medicinal products in the XeVMPD system in accordance with EU regulatory guidelines.
- Quality Assurance: Ensures the accuracy and quality of data entered into the system. Regularly reviews and cleans data to maintain its integrity.
- Regulatory Compliance: Ensures compliance with all relevant regulatory guidelines related to XeVMPD. Keeps up-to-date with changes in regulations and implements them in data management practices.
- Collaboration: Works closely with other departments, such as Regulatory Affairs and Pharmacovigilance, to collect necessary information and ensure its correct entry into the system.
- Reporting: Generates regular reports on data management activities and presents findings to relevant stakeholders.
- Training: May be responsible for training other team members on XeVMPD data entry and management practices.
- Problem Solving: Addresses and resolves any issues or discrepancies in the XeVMPD data promptly.
Requirements:
- Degree in Pharmacy, Life Sciences, or a related field.
- Experience in Pharmacovigilance or Regulatory Affairs.
- Strong attention to detail.
- Knowledge of EU regulations related to drug safety.
- Proficiency in data management systems.
