Vinay Ch Email & Phone Number

Darmstadt, He, De

Darmstadt, Hesse, Germany

• Led a high-performing managed services team for an AWS cloud-based drug safety application, Life Sphere Multitenant (LSMT). The team comprised 2 technical leads, 3 developers, 5 testers, and 3 analysts.• Manage project delivery through comprehensive planning, stakeholder management, risk assessment, budget/resource management, and quality control.• Collaborated with clients to plan and implement change initiatives, including reviewing and approval of Validation Plan, OQ Protocol document, OQ Summary Report, and Validation Summary Report (VSR) as per the ITIL framework.• Monitored and reported key performance indicators (KPIs) to stakeholders, highlighting IT service performance and areas for continuous improvement.• Participated in audits and inspections for clients, ensuring smooth compliance with regulatory standards.• Provided RCA and CAPA for process-related issues identified during the operational phase, driving continuous improvement.• Defined streamlined global business processes for the operational phase, enhancing efficiency, consistency and ensuring successful project execution.Played a pivotal role in supporting Global Pharmacovigilance (PV) in compliance with GVPs and safety regulations. Supported implementation of safety and risk minimization measures.• Managed PV issues for marketed products, aligning with global and local quality documentation.• Developed tailored reports to facilitate internal audits and Health Authority inspections, ensuring compliance transparency.

Darmstadt Area, Germany

• Functioned as the Technical Lead and change lead, collaborated with clients for requirements elicitation and change planning for business requirements using JIRA tool.• Designed automated and manual quality check workflows in ARISg, improving data accuracy and regulatory compliance.• Utilized Rule-based automation (RBA) to devise Case data validation checks through JScript & PL/SQL, enhancing data quality.• Engineered custom forms to meet specific client needs, enhancing user experience and data collection efficiency.• Employed Natural Language Processing (NLP) to develop custom import mapping, enabling automatic case creation from various partners and health authorities.• Successfully performed Migrations for Total safety suite (ARIS\LSMV) and implement data cleansing and validation procedures to maintain data integrity. • Achieved seamless integration with external applications through REST API, streamlining data exchange processes.• Successfully integrated Microsoft O365 accounts with LSMV for automatic case creation, improving efficiency.• Led disaster recovery efforts to ensure system stability and data integrity.• Successfully decommissioned servers and applications in a systematic manner.• Configured Single Sign-On (SSO) in LSMV by integrating with Microsoft AD, bolstering security and user convenience.

India

• Developed intricate distribution logic using PL/SQL within the ARISg application, ensuring automatic submissions aligned with FDA and EMA regulatory standards.• Extensively worked in complex coding using oracle PL/SQL in delivering customized solutions for Company Product Dictionary, form changes, and data validations in ARISg\IRT application.• Worked on data migration from legacy systems to new systems, validating data accuracy, and resolving any data-related issues.• Created customized Aggregate reports in compliance with health authority requirements, enhancing regulatory adherence.• Utilized Spotfire to create informative dashboards for tracking case management performance and KPIs.• Collaborated closely with case processing teams, translating technical errors into business terms to expedite case submissions.• Successfully integrated Microsoft O365 accounts with ARISg\IRT for automatic case creation, improving efficiency.• Established automated monitoring for Microsoft O365 accounts to ensure timely email processing and case creation.• Orchestrated end-to-end monitoring to ensure system high availability and performance.• Installing and setting up Total safety suite (ARISg, IRT-OST, EDI, B2B Gateway) applications, including customization using JBoss. Enabled SSO login and SSL based data encryption using HTTPS.• Worked closely with compliance teams to identify root causes and provide Corrective and Preventive Actions (CAPA) for late reporting.• Extensively worked on the MedDRA, WHOD, JDD and JHC recoding.

Bengaluru Area, India

• As an L3 (Level 3) software engineer, I specialized in addressing and resolving complex defects within software applications or systems. In this role, my primary focus was on investigating and troubleshooting intricate issues reported by end-users or detected through testing and monitoring processes.• Developing and executing comprehensive test cases to validate defect fixes and ensure that the software meets quality standards.• Managing and prioritizing defect escalations based on their severity and impact on end-users or critical business operations.• Developed customer requirements on key modules of IRT-OST and ARISg, including form changes, workflow creation, and data security enhancements.• Monitored and optimized system performance through collaboration with engineering teams, including scaling infrastructure and database tuning.• Collaborated with stakeholders for release planning of critical application bugs and enhancements.

Banglore, India

QC Testing for ARISg 7.1 and agXchange 7.1 IRT OST.To execute the TCD’s and identify application defect.To analyze and document testing resultTesting on following modules agXchange IRT OST modules like Reports, Administration Preferences, Creating Roles, Configuring User Accounts, Application Settings, AGX Templates, communication templates, fax servers, working with Transport Settings, Schedulers, understanding Logs etc.Testing on following modules ARISg modules like installation parameters, library, ESM, report, Workflow designing, setup, validations, maintenance etc.

B.Tech, Ece

Activities and Societies: Cricket League, Group discussion events, Organized College Fest, Presentation, Organized summer internship.

Class Xii

Class X