Reg. Affairs Officer - Bengaluru, India - IQVIA

IQVIA

Verified Company

Bengaluru, India

3 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

Job Description

Data Management: Ensuring accurate and uptodate product information is entered into the xEVMPD database, including details such as product name, active substances, dosage forms, indications, and packaging information.
Database Administration: Overseeing the management and administration of the xEVMPD database, including user access control, data validation, and system maintenance.
Regulatory Compliance: Ensuring compliance with EU regulations and guidelines for the electronic submission of product information to regulatory authorities, including timely and accurate updates to the xEVMPD database.
Collaboration and Communication: Coordinating with internal stakeholders, such as regulatory affairs, pharmacovigilance, and quality teams, to gather and verify product information. Collaborating with external partners, such as marketing authorization holders, to obtain necessary data for submission.
Data Quality Assurance: Conducting data quality checks and audits to ensure the integrity and accuracy of product information within the xEVMPD database. Resolving any discrepancies or errors identified during the validation process.
Reporting and Documentation: Generating reports and preparing documentation related to xEVMPD submissions, data updates, and compliance activities. Maintaining records of submissions and ensuring proper documentation of changes and updates.
Training and Support: Providing training and support to internal stakeholders on xEVMPD requirements, data entry processes, and system usage. Assisting users in troubleshooting issues related to data entry or database functionality.
Stay Updated with Regulations: Keeping abreast of changes and updates in EU regulatory requirements for xEVMPD and ensuring compliance with evolving guidelines and regulations.
Process Improvement: Identifying opportunities for process optimization and streamlining data management workflows related to xEVMPD submissions. Implementing improvements to enhance efficiency and data accuracy.