RA Specialist - Mumbai, India

A XeVMPD (Extended EudraVigilance Medicinal Product Dictionary) Associate is a professional who 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 for this role typically include a degree in Pharmacy, Life Sciences, or a related field, along with experience in Pharmacovigilance or Regulatory Affairs. Strong attention to detail, knowledge of EU regulations related to drug safety, and proficiency in data management systems are also essential.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com