Divya Mothukuri

I am having around 10 years of experience in Veeva vault & Pharmacovigilance, Validation, clinical data analyst and Quality Engineer in pharmaceutical and medical device industries. Having experience in Veeva Vault Configuration, designing Lifecycles and workflows. Medical Devices (ISO 13485, IEC 62304). Managed clinical trial data by ensuring data integrity and compliance with regulatory standards. Desined and implemented data management plans including data collection, validation and reporting processes Having experience on automated site feasibility and selection process leveraging vaults scoring and survey tools for identifying high performing clinical sites. Having experience and knowledge on configuring and optimizing of veeva vault study start up workflows. Configured Site Connect access and sponsor site workfkows. Having experience in developing site package definitions, decreasing manual load and improving site turnaround.. Involved in Design input/output, verification & Validation procedures and updating and maintaining the documents. Having experience of storing and managing clinical trial data, ensuring scalability and high availability. Developed and maintained electronic data capture EDC systems. Having experience in Investigational new drug Application (IND) in RIM Veeva Vault. Knowledge in managing INDs in Veeva Vault RIM. Having experience in Veeva Vault PromoMats. Managed end to end lifecycle of promotional materials using veeva vault PromoMats, ensuring compliance with regulatory guidelines. Having experience in veeva promoMats content management. Proficiency in Veeva Vault applications like PromoMats, Medcomms, and eTMF. Experience with ETQ reliance for quality management systems. Good expertise in developing the following validation deliverables- Risk Assessments, Regulatory Assessments, Gap Analysis documents, Validation Plans, Qualification Protocols, Validation reports, IQ/OQ/PQ. Developed and implemented corrective action and preventive action plans (CAPA), Nonconformance Report (NCR). Having experience on collaborating with cross functional teams to define UAT requirements. Knowledge in documenting and tracking UAT results. Expert in drug therapy monitoring and patient counselling. Proficiency with standard MS office skills. Good leadership and organizational skills can work with the team as well as independently. Good verbal, written, interpersonal and communication skills to interact with users and team members, to understand and meet their business & functional requirements. Maintaining an excellent knowledge of case processing conventions and guidelines, and international drug safety regulations Working knowledge and familiarity with medical terminology Worked on Patient leaflet information on various drugs. Excellent analytical, organizational, interpersonal and communication skills, with an ability to work independently as well as within a team environment. Good understanding of Software Development Life Cycle (SDLC), Agile Methodologies. Working as Vault administrator to support daily operations and assisting users with technical issues Provide front-line, second level technical support as part of the IT Operations team to deliver exemplary customer service. Have basic level ITIL (Information Technology Infrastructure Library) support process knowledge, have experience in Triage incidents, assess & estimate change request, track escalations, perform root cause analysis and work with vendors to resolve system issues. Actively handled document migration, mapping, and various loader activities. Configure and update atomic security for fields under different lifecycle states. Using JIRA tool, supported the configuration, development, and release operations in an agile methodology. I have knowledge of linking JIRA repositories in Veeva vault. Supporting Document & Object Lifecycle and Workflow configuration activities to design, develop, test, and implement system enhancements in accordance with business process requirements. Creating and updating Validation rules, Page Layouts, configuring Object Types. Configure Document Type/Subtype/Classification, Document & Binder Templates. Create/Update new Document & Object Fields, configure Field Dependencies, create/update records in Pick list. I have knowledge in connection between a RIM Submissions Vault and a Clinical Operations eTMF Vault automates data sharing between the two applications. It supports the automatic transfer of Product, Study, and Site data and documents. I understand Vault RIM Submissions is an end-to-end application designed to manage the authoring, review, approval, and assembly of regulatory submissions content. It handles various types of content, including clinical study reports, manufacturing information, nonclinical reports, summaries, and labeling. Having knowledge on clinical eTMF, CTMS. Vault Submissions includes pre-configured document types aligned with the required content for regulatory submissions (Clinical, Nonclinical, Quality, Regulatory, Pharmacovigilance, and Literature). Ensuring the system is validation ready. Assigning and completing training with a complete audit trail in Veeva Learning Management System (VLMS)Authorized to work in the US for any employer.

• Presented an oral paper presentation on “Clinical comparison of the efficacy and safety of intra-articular injections of sodium hyaluronate and methylprednisolone in the treatment of osteoarthritis of knee.”
• Presented a poster presentation on rheumatoid arthritis at VELS school of pharmaceutical sciences 2014, Pallavaram, Chennai.
• Presented a poster presentation on Acute renal failure at VELS school of pharmaceutical sciences 2015.

• Clinical comparison of the efficacy and safety of intra-articular injections of sodium hyaluronate and methylprednisolone in the treatment of osteoarthritis of knee, Research Journal of Pharmacy and Technology
• A prospective study on health-related quality of life among hypertensive patients, Research Journal of Pharmacy and Technology