Smita Singh Email & Phone Number

Palo Alto, California, United States

- Manage PV System Projects and engage with vendor to determine scope, goals, and objectives in safety/PV related projects.- Support safety systems users and provide system administration support for global safety applications.- Implement MedDRA and WHO upgrade activities.- Support Data Management activities globally, including safety data outputs/line listings for PBRER/PSUR, DSUR, regulatory inspections using QlikView- Support Jazz Pharmaceuticals Global Safety Database system… Show more - Manage PV System Projects and engage with vendor to determine scope, goals, and objectives in safety/PV related projects.- Support safety systems users and provide system administration support for global safety applications.- Implement MedDRA and WHO upgrade activities.- Support Data Management activities globally, including safety data outputs/line listings for PBRER/PSUR, DSUR, regulatory inspections using QlikView- Support Jazz Pharmaceuticals Global Safety Database system (Argus) configuration changes, User access, enhancements activities and maintain configuration documentation.- Generate standard listings ad hoc listings from Safety systems (Argus, QlikView).- Collaborate with project team and other members of the safety systems team.- Perform QC check on configuration changes. Identify discrepancies between the request and the implementation and resolve or initiate their resolution in collaboration with R&D IT and/or vendor(s)- Understand Safety/PV processes to support process improvement initiatives.- Support Head of PV Systems and other PV Senior Management members in discussions to help anticipate future business needs and opportunities and communicate where technology can help.- Work with Head of Safety/PV Systems to raise new project proposals and support definition of the business case, conduct assessments of processes and detail requirements.- Collaborate with project team and other members of the Safety/PV systems and data management team to determine scope, goals, and objectives in DSPV-related projects.- Collaborate with R&D IT and project team to define solutions that deliver business value. Show less

Noida, Uttar Pradesh, India

. Responding to RFP’s. SME for E2B internal processes and implementations. Understanding PV business needs and defining requirements for E2B R3 Implementation including E2B R3 guidelines, Profile Customizations, Business Process, Technical implementations.. Contributing to the User Requirement Specification, IQ, OQ and PQ scripts authoring and execution. Collaborating with the Global PV Head and relevant stakeholders to ensure the drug safety systems & related interfaces to be… Show more . Responding to RFP’s. SME for E2B internal processes and implementations. Understanding PV business needs and defining requirements for E2B R3 Implementation including E2B R3 guidelines, Profile Customizations, Business Process, Technical implementations.. Contributing to the User Requirement Specification, IQ, OQ and PQ scripts authoring and execution. Collaborating with the Global PV Head and relevant stakeholders to ensure the drug safety systems & related interfaces to be always complaint with the latest regulations and agreements.. Supporting the Integrated Case Management Automation Platform team to effectively perform automatic entry of adverse event cases in Argus System which uses advance intelligent automation technologies like ML and NLP Show less

Mumbai, Maharashtra, India

• Worked on PV business needs and defining requirements for E2B R3 Implementation including E2B R3 guidelines, Profile Customizations, Business Process, and technical implementations.• Contributed to the User Requirement Specification, IQ, OQ, and PQ scripts authoring and execution.• Collaborated with the Global PV Head and relevant stakeholders to ensure the drug safety systems and related interfaces to be always complaint with the latest regulations and agreements.• Managed… Show more • Worked on PV business needs and defining requirements for E2B R3 Implementation including E2B R3 guidelines, Profile Customizations, Business Process, and technical implementations.• Contributed to the User Requirement Specification, IQ, OQ, and PQ scripts authoring and execution.• Collaborated with the Global PV Head and relevant stakeholders to ensure the drug safety systems and related interfaces to be always complaint with the latest regulations and agreements.• Managed end-to-end configuration of the global system including maintenance of company's PLS (product-licenses studies) configuration, set up of expedited reporting rules in accordance with HA regulations, SDEA partner agreements, ICSR validations, and edit checks.• Created complex SQL queries for advance conditions of the reporting rules/Workflow. Show less

Leiden, South Holland, Netherlands

PV Functional Consultant @Tata Consultancy Services• Responsible for projects related to safety information management and Pharmacovigilance team using Oracle Argus Safety web application• Design and development of Reporting Rules to meet individual US, EU, Japan and Global reporting requirements.• Responsible for reviewing safety database exchange agreements (SDEAs) and creation of Configuration Baseline Documents, Reporting Rules, Advance Conditions, and Destinations.•… Show more PV Functional Consultant @Tata Consultancy Services• Responsible for projects related to safety information management and Pharmacovigilance team using Oracle Argus Safety web application• Design and development of Reporting Rules to meet individual US, EU, Japan and Global reporting requirements.• Responsible for reviewing safety database exchange agreements (SDEAs) and creation of Configuration Baseline Documents, Reporting Rules, Advance Conditions, and Destinations.• Engaged in the Expedited Reporting of Individual Case Safety Reports (ICSRs), Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR), and Suspected Unexpected Serious Adverse Reaction (SUSAR) Line Listings to National Competent Authorities and concerned Ethics Committees.• Resolved issues related to E2B (an international standard for transmitting medicine adverse event reports) setups, submissions, and acknowledgement for Regulatory Authorities and License partners.• Responsible for working closely with clients to ensure the delivery of timely and quality services with the highest customer satisfaction• Understanding the business requirements of multiple regulatory authorities through Use Case documents and performing required configurations • Developing and deploying technical solutions to drive business impact• Define role profiles as per the construct and hire best-fit team members• Deputed to The Netherlands for 3 years to help the team grow functionally while increasing the scope of business for TCS Show less

Noida Area, India

IT Analyst @ Tata Consultancy Services• Providing maintenance and support for an Argus Safety suite 5.0.• Resolving day-to-day tickets logged by customer in compliance with Service Level Agreement using REMEDY.• Responsible for creation of Installation Qualification, Operational Qualification, and Performance Qualification scripts in ALM• Responsible for developing business reports using SQL/Cognos• Configuration of PLS (products-licenses-studies), Reporting Rules in… Show more IT Analyst @ Tata Consultancy Services• Providing maintenance and support for an Argus Safety suite 5.0.• Resolving day-to-day tickets logged by customer in compliance with Service Level Agreement using REMEDY.• Responsible for creation of Installation Qualification, Operational Qualification, and Performance Qualification scripts in ALM• Responsible for developing business reports using SQL/Cognos• Configuration of PLS (products-licenses-studies), Reporting Rules in Argus 5.0.2• Incident/Problem/Change Management• Responsible for creating and executing the Test Cases, Test Scripts and Test Plans• Effective Client Management Show less

Noida Area, India

Systems Engineer @Tata Consultancy Services• Worked as a SME (Subject Matter Expert) for ADMS (Advitium Drawing Management System), a project customized to implement a common solution for AutoCAD drawings management through a program called Advitium.• Troubleshooting and resolving technical and functional issues with the users in different Zones of the world.• Completing changes/enhancements in the system as per business requirements.