Divya Chawla

Drug Safety Specialist

PAREXEL International

Mohali

04.2024 - Current

4 years of experience in the management of the regulatory information including Chemistry, Manufacturing and Control of Medicinal products and Vaccines, registrations, submissions, eCTD publishing, lifecycle state management.
Hands on experience of Veeva Vault: Event creation, Submission record creation, Regulatory objectives creation, Registrations creation, Updating registration joins and its lifecycle state,Core package creation, Dispatches
Responsible for maintaining and tracking changes in the life cycle of a medicinal product such as pharmaceutical strength, packaging, manufacturing sites, storage conditions or shelf life, etc. in the regulatory database per the information received from the client.
Creation of variations in the regulatory database to track labeling or quality changes, for International, US and European Union region for National, Centralized, Mutual Recognition and Decentralized procedures.
Assisting client to manage and respond to Health Authorities questions and commitments
Providing end to end support to client for any Veeva related queries through Zoom collaboration room.
Assisting client to Import dossier within Veeva Vault, Creating submission content plan,Report extraction.
Assisting client with the eCTD submission structure.
Training in xEVMPD, IDMP
Currently working on Whatfix as well which works on the automation, this is to assist client with all above processes.
Mailbox screening, timelines management, sharepoint handling.
My responsibilities also include Mentoring new joiners, providing them the training on Veeva Vault RIM.
Working as the back up process owner to manage CMC process for administrative and quality data.