﻿SUMIT SHARMA
+918800775716
summit.sharma81@gmail.comExperience Summary:
PV Consultant having 8.7 years of experience in Software Testing and Validation.
More than 4 years’ experience of extensively working in PV domain including Oracle Argus Safety, CSV and GxP compliant systems.
Experience in Test Automation, BI Report Testing (Power BI &amp; SAS Analytics) and Mobile testing. 
Well versed with working on offshore/onsite model, GxP, GAMP5, 21 CFR Part11.
Responsible for Test Planning &amp; Validation, Test Strategy, Test case creation, Test Management and Change Management across the projects.
Excellent working knowledge &amp; hand on experience of SDLC, STLC, Agile, V model (Verification &amp; Validation process) and Computer System Validation (CSV).
Specialization includes Functional Testing, System Integration Testing, Report Testing and Argus Safety Validation Practices.
Excellent client handling skills, have been involved in onsite workshops and PQ executions.
Excellent communication and interpersonal skills, quickly adapt to Industry, domain and organization specific SOP’s and guidelines.
Software Skill Set:
Languages Java, SQL
Database MySQL, MS SQL Server, Oracle SQL Developer
Software/components
/SDK/tools Selenium Web Driver, HP ALM (QC), Fiddler, JIRA, TFS
OS Windows, Linux, Android, iOS
Domain Experience Life Sciences (Pharmacovigilance), Finance, E – Commerce and Energy
Professional Experience:
Organization: VITRANA (Virtuous Transactional Analytics Private Limited) (15th April 2021 to Present)
Designation: Principal Consultant (Validation)
Project name:  HiLIT PV Implementation 3.0 for Alexion Pharmaceuticals Global Drug Safety (GDS) – (July 2021 to Present)
HiLIT PV is a Case Intake application used to unlock safety/clinical data stored in semi-structured/unstructured format and derive meaning out of it with DeMystifier service. It employs state-of-art Machine Learning and NLP algorithms to intelligently read/extract/harmonize text out of semi-structured data such as CIOMS/MEDWATCH PDF reports and unstructured data such as narratives, clinical notes and emails. It provides Out-of-the-box integration services with safety systems like Argus, achieving true case-intake automation. 
Roles and Responsibilities:
Analysis of Delta requirements from the Risk Assessment document received from other 3rd parties and finalizing the number of PQ scripts to be delivered.
Inputs to the QP (Quality Assurance Plan) and update as per necessary changes given by client.
Validation and Test Plan Creation and update as per necessary changes given by client and routing for approval.
End to end functional testing of HiLIT (Source) and it’s integration with Argus (Destination).
Defect Reporting, tracking, retesting and closure activities as per the defined QMS.
Authoring the PQ scripts covering all the functional requirements identified during Requirement Analysis.
Performing the reviews and dry runs of PQ scripts authored by other team members.
Routing the PQ scripts for pre-approval in Val Genesis.
Supporting the formal Execution of the PQ scripts and handling the deviations, if any as per the defined QMS.
Validation &amp; Test Summary Report creation, update as per review and routing to the stakeholders for approval.
Project name:  Novartis Transform PV Implementation for Korea E2B (R3) – (April 2021 to June 2021)
Transform PV is a product that converts the E2B R3 files to the local language files. Here the implementation was done to convert the B3 (alphanumeric Drug Code) and C3 (alphanumeric Medicinal Product ID) codes into the MFDS codes for respective tags for MFDS E2B R3 reporting.
Roles and Responsibilities:
Requirement Analysis and finalizing the number of OQ scripts to be delivered.
Validation and Test Plan Creation and update as per necessary changes given by client and routing for approval.
Authoring the OQ scripts covering all the functional requirements identified during Requirement Analysis.
Performing the reviews and dry runs of OQ’s scripts authored by other team members.
RTM Creation, maintain and updates as per the changing requirements.
Defect Reporting, tracking, retesting and closure activities.
Routing the OQ scripts for pre-approval in PROTON (HP ALM).
Formal Execution of the OQ scripts, reporting the deviations as per the defined QMS.
Deviation Reporting and closure as per the defined QMS.
Validation &amp; Test Summary Report creation, update as per review and routing to the stakeholders for approval.
Organization: Incedo Technology Solutions Limited (13th August 2019 to 14th April 2021)
Designation: Test Lead (Life Sciences)
Client Name: Syneos Health (Inventive Health &amp; INC Research)
Project name:  PV Hub Safety Case tracking Argus Integration &amp; Reporting (August’2019 to Present)
Database: MS Azure SQL Server (SaaS)
Test Management Tool: TFS
Syneos Health proposed the development of Hub Safety Case Tracking &amp; Reporting program for case processing of individual safety cases which are created within PV hub application and imported from Argus Safety. The system performs end to end case processing followed by rigorous quality (QC) and medical review (MEDQC) workflows.  The implementation also includes Safety Case Audit Reports built on Power BI platform which is configured with the PV Hub Safety Case Tracking datalake.
Roles and Responsibilities:
Working closely with Business Team to understand the requirements.
Authoring the Test Plan and Test strategy document and routing for formal approval.
Authoring and Reviewing OQ scripts and routing for approval post review by Validation Manager and respective stakeholders.
Detailed functional testing of PV Hub application and Reports in Power BI &amp; SAS Viya platform.
Integration and Back End data validation of PV Hub, BI Reports datalake.
Responsible for RTM creation/update as per the changing requirements, Risk Analysis.
Dry run and formal execution of OQ scripts.
Preparing Defect Reports and tracking the defects raised.
Preparing and sharing the Test Summary Report after each test cycle with the stakeholders.
Also involved as a reviewer for all the GxP compliant Project artifacts across all the QA_CoE projects.
Organization: QA InfoTech (May 2017 to August 2019)
Designation: Lead Quality Engineering
Client Name: Foresight Group (IQVIA)
Project Name:  Novartis Pharma (AURORA) – Argus Global and Japan Implementation 8.1.2.3 (March 2019 to August’2019)
Database: Oracle SQL Developer 
Test Management Tool: HP ALM (Proton)
Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland and one of the largest pharmaceutical companies by both market capitalization and sales across the globe, it is divided into three operating divisions: Innovative Medicines, Sandoz (generics) and Alcon (eyecare) worldwide.
Configuration of Argus E2B R2, R3 and PMDA customization for Novartis Pharma.
        Roles and Responsibilities:
Understanding the requirements for E2B R3 customizations for EMA and PMDA.
Responsible for RTM updates as per the changing the requirements. 
Authoring of the Performance Qualification scripts for successive phases of the project.
Responsible to coordinate for business dry run of PQ scripts by Cognizant validation team.
Coordinating with Novartis Business team based in Basel Switzerland for PQ script approvals for formal execution.
Performing the Peer reviews for the PQ scripts authored by other team members.
Mentoring the junior QA Engineers
Responsible for providing support for manual ACK generation during peer and business dry runs.
Onsite support to client during the PQ scripts (UAT) dry run and formal workshop.
Client Name: Foresight group (IQVIA)
Project name:  Sun Pharma - Argus J Implementation 8.1.2 (November 2018 to February 2019)
Database: Oracle SQL Developer (12C)
Test Management Tool: Validator 
     Configuration of Argus J and PMDA customization for the Indian Pharma giant Sun Pharma.
The project involves configuration of Argus J component with Argus Out of the box functionalities and PMDA customizations.
 Roles and Responsibilities:
Understanding the requirements for Argus J component.
Coordinating with the client technical team and QA for OQ and PQ authoring review and updates as per the Sun Pharma QA compliance and SOP’s.
Provided the trainings to team members for Sun Pharma QMS tool Validator for OQ execution and defect reporting.
Taken ownership for authoring of the Performance Qualification scripts for Argus J standard functionalities and workflows.
Dry run of Operational Qualification scripts for Argus J standard out of the box functionalities. 
Authoring of Operational Qualification scripts for PMDA customizations.
Travelled to Japan and provided onsite support to client during Performance Qualification scripts dry run workshop and successfully got the scripts approved by Sun Pharma QA head.
Travelled to Japan for providing onsite support during Performance Qualification (PQ) scripts formal execution workshop (UAT).
Completed the deviation reporting, change controls as per the standard Sun Pharma QMS and SOP’s.
Prepared the PQ execution summary report and shared with Foresight and Sun Pharma stakeholders.
Successfully completed the PQ executions (UAT) onsite within the planned timeframe.
Client Name: Foresight Group (IQVIA)
Project Name:  DSP – Argus 8.1.2 Upgrade ( HYPERLINK "https://www.ds-pharma.com/" Sumitomo Dainippon Pharma) (May 2018 to October 2018)
Database: Oracle SQL Developer 
The project involves Configuration and customization of Argus E2B R2, R3 and PMDA profiles for World’s Leading Pharmaceutical Company – DSP based in Osaka Japan and Boston USA providing healthcare solutions worldwide in compliance with the Regulatory authorities FDA, EMA and PMDA Japan.
Roles and Responsibilities:
Authoring of Operational Qualification (OQ) scripts as per E2B R2 and R3 customization and Data transformation requirements.
Creating and updating the RTM as per the changing user and functional requirements.
Authoring of the Performance Qualification scripts for onsite execution by the client.
Validating the customizations for E2B R2, R3 and PMDA reports on Argus test environment configured as per the CBD approved by the client.
Creating and testing negative and positive scenarios while testing the customizations and reports.
Dry run and Final Execution of Operational Qualification scripts, defect reporting, regression and retesting and peer reviews.
Travelled onsite (Japan), providing onsite support to client during ongoing Performance Qualification (PQ) scripts execution (UAT), change control and deviation reporting.
Successfully completed the PQ execution onsite as per the Standard QMS, deviation and change control closures following the required RCA.
Prepared the PQ execution summary report and shared with the stakeholders.
Client Name: Foresight Group (IQVIA)
Project Name:  Sanofi AEGIS (May 2017 to April 2018)
Database: Oracle 11g
Project Description: 
The objective of the Sanofi AEGIS program was to create a centralized system (AEGIS - Adverse Event Global Information System) for the reporting of adverse events caused due to pharmaceutical products such as Drug, Device and Cosmetics and providing the ICSR and Expedited Reports in compliance with the PV laws and regulations to the regulatory authorities such as FDA in USA, EMA in Europe and PMDA in Japan.
The reporting is achieved by Oracle Argus Safety Suite by its integration with the existing Sanofi systems and configuration of Argus 8.1.1 as per the requirements.
Roles and Responsibilities:
Authoring the OQ scripts for the configuration and Integration of Argus Global and Japan.
Responsible for end to end functional, system integration testing and regression testing of the interfaces with Argus Configuration.
Responsible for testing of the data from source to existing AEGIS databases.
Validating the customizations for E2B R2, R3, CIOMS and PMDA reports for different profiles and Reporting Destinations.
Testing both Argus UI and database for different interfaces by creating and executing SQL queries
Dry run and Formal Execution of Operational Qualification scripts, defect reporting, retesting/regression and peer reviews.
Giving inputs for documenting OQ Summary Report which includes the details of the test execution process, test results and deviations raised during the test cycle (OQ Execution).
Responsible for performing root cause analysis of the defects raised during the SIT rounds.
Responsible for impact analysis of the change controls raised by client in successive SIT’s.
Provided support during ongoing PQ Execution (UAT) for Japan and China.
Previous Organizations:
IDC Technologies (July 2016 to March 2017)
Smart Utility Systems (May 2015 to June 2016)
Chetu India Pvt. Ltd. (Oct. 2013 to May 2015)
Genesis Technologies (Feb’12 – Dec’12)
Academics &amp; Visa Details
Bachelor of Engineering in Information Technology from RGTU Bhopal, 2011, 67%.
Holding 5 Years Japan Visa valid till May’2024



