Maha Tripura Sundari P

Operations Specialist 2, Regulatory Reporting Lead @IQVIA

County Dublin, IE

Manage customer interface and communication for pharmacovigilance projects/ programs. Represent lifecycle safety and serve as the primary point of contact for all internal and external customers/ stakeholders. Manage customer deliverables for assigned projects and bring continuity to project design and delivery, and responsible for project planning, defining project/ scope management, quality management and project financial management. Act as an account owner over a program or customer portfolio and report program/ portfolio level metrics and provide oversight of projects. Provide leadership structure for customer service interface from scoping stage, through proposal generation, bid defense to transition of work and service delivery, and throughout the development and commercial life cycle of the product. Manage realization/ profitability for drug safety projects, and update of financial systems, including revenue recognition, invoicing, project budget review, project financial analysis, pursuit of change orders. Participate in client and internal audits and inspections. Liaise with quality assurance staff and management in the compilation of corrective action plans. Work in a customer centric fashion analyzing current and future customer needs and actively developing innovative, cross-functional strategic solutions to meet customer needs.Leading of Regulatory reporting projects for clinical trials to interface with the customers and internal stakeholders on all the regulatory reporting matters to conduct the clinical trials in accordance with legislated requirements and quality standards. Extensive experience in the safety reporting to regulatory authorities, ethics committees, clinical trial sites with overall knowledge of reporting requirements of global countries (US FDA, EU regulations, MHRA, HSA, Taiwan, and all multiregional regulations across globe), reporting guidelines, handling of significant safety issues, etc.

Periyar University

Master's degree, Biotechnology

VR institute of advanced sciences

Bachelor of Science - BS, Microbiology, General