Aditya Reddy Geetla

Deputy Manager - Global Labelling @Freyr Solutions

Hyderabad, IN

Support Local Operating Companies (LOCs), Global Labeling Leads (GLLs), European Regulatory Leads (EURLs), and U.S. Regulatory Leads (USRLs) in creating new labeling events (core or local) in the MEDIVA system (Veeva Vault) and TRAIL system (Tracking Regulatory Affairs Implementation of Labeling)- Manage dependency requests to ensure accurate system configuration- Share country dependency lists with stakeholders for proper setup in MEDIVA and TRAIL- Conduct quality checks of new labeling events in MEDIVA for accuracy and compliance- Perform follow-ups with LOCs and regulatory leads for records nearing submission due dates- Share overdue and upcoming submission reports with stakeholders to ensure compliance- Provide post-approval support for CCDS changes and updates (e.g, deferrals)- Create PSMF Annex F documents using MEDIVA and TRAIL reports- Perform quality checks on PSMF Annex F documents and share with the Pharmacovigilance Manager- Support third-party inquiries/audits (e.g, Regulatory Authorities, legal, partners) regarding historical product labeling- Liaise with cross-functional partners in GPSE, LOCs, Global Quality, GlobalManufacturing and Supply, and Global Regulatory Affairs- Handle client calls and manage team activities to ensure smooth operations- Assign tasks and monitor team progress- Manage labeling folders in Freyr and client systems- Train new associates on processes and systems.