Safety Engineer
Resume:
Aditya Razdan – ************@*****.***
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Background
Aditya has over Fourteen years of IT experience out of which over Eleven years have been in Life Sciences and Drug Safety and surveillance consulting. He has extensive experience in Drug Safety and Pharmacovigilance, Process Compliance & Improvement, Quality Assurance, Life Sciences Regulatory Compliance for ICH, FDA, DSCSA, EMA, PMDA - 21 CFR Part 11 and GAMP Framework. Expertise in Computer Systems Validation as per GAMP framework pertaining to Life Sciences domain under GxP guidelines. He works closely with Organizations for implementation of their PV systems and ensure post-handover they are managed in compliance with local regulations and company policies at a local, regional and global level. He has also been involved in Performing Gap Analysis, Document Management, Incident Management and Change Control Management and has worked under the skeleton of SEI-CMM Level 5/ ISO 9001 compliant process driven and tool-based environments. He regularly works on projects for implementing continuous improvement activities to optimize productivity and quality. Aditya has also been responsible for conducting Audits to assess the health of projects and ensure compliance to processes and standards. He has been involved in Management, configuration and validation of Argus Safety/ Insight, database upgrades and migration projects. Prior to joining Iqvia, Mr. Razdan was employed as a Senior Consultant at Foresight Group LLC, a Senior QA at Sapient and a Software Engineer at HCL Technologies. Capabilities
Project Management
• Microsoft Project, Basecamp, Jira
Diagramming Tools
• Microsoft Visio
Project Methodologies
• Agile approach- Scrum
• Kanban
• Waterfall
• Spiral
• Iterative
Applications
• Oracle Argus Safety Suite
• Oracle AERS
• ArisG
Technology
• Document Management- Microsoft SharePoint, Box
• Office- Microsoft Office Suite, Open Office
• Test Management Tool- HP Quality Center, Jira
• Database Tools: Toad and Oracle SQLPLUS
Aditya Razdan – ************@*****.***
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Summary
Project Manager
Successfully managed large and complex projects with a demonstrated track record of delivering within approved plan, scope and budget and business outcomes. Responsible for delivering multiple projects
(Migration, Upgrade, fresh installation of PV systems and Serialization) and setting up management processes and best practices which were replicated effectively across the company. Managed a group of 25 direct and indirect reports including Team Leads, Business Analysts, DBAs, Technical Analysts and testers for multiple small, mid and large level pharma clients- o Managed multiple medium sized teams. Conducted status/tech support meetings with clients across Geographic areas- USA, Europe and India on a regular basis o Experience in applying various Agile activities like planning/review and grooming sessions
o Conducting daily stand up, supporting team to maintain their burn out chart o Author detailed specification documents like Project Plan; scrutinize proposals, and contribute in drafting SOW's, Business Requirement Document (BRD) and Use Case Specifications
o Author and track project Scope, Objectives, Risks, Budget and Work breakdown Structure
o Task allocation, oversight, mid and high-level track planning and project execution o Regularly report progress to the sponsor, stakeholders and Steering Committee o Encourage collaboration between all stakeholders and manage sponsor and stakeholder expectations
o Perform project management activities from Project Initiation to Project closure o Identify and assess risks related to regional or cross-regional project activities o Create Risk Evaluation and Mitigation Strategy, communicate and escalates risks and lead cross-functional teams to address any risks or non-compliances o Successfully delivered projects that were subject to time and cost constraints by managing the resources, deliverables and project scope
o Instrumental in improving the company’s Business Analyst practices by implementing agile principles-based processes
o Ensures PV inspection-readiness within the Organizations for internal and External PV audits as required for GVP related inspections
o Identifying and interacting with Vendors for key PV deliverables Senior Principal Consultant
Client Engagement Manager formulating business expansion strategies in European market involving Migration and upgrade projects of Oracle AERS 4.x, ArisG and custom (in house) source safety systems to Oracle Argus Safety 7.x and 8.x for at client locations- PharmaMar (Spain), Alk Abello (Denmark) and Novo Nordisk (Denmark)
o Pre-Sales support- providing business and functional inputs for RFP o Conduct Configuration Workshops for gathering User and Functional Requirements o Conduct Data Migration workshops for source to target Safety systems o Experience in applying business acumen towards requirement gathering session, interviews, questionnaire, prototyping, brain storming, process modeling and analysis o PV business process re-engineering and optimisation o Authoring, review and maintenance of Functional / Non-Functional Requirement Specifications
(FRS), System Requirements Specifications (SRS) and Product Documentation including version control
o Configuring Argus Safety environments- Development, Validation, Training and Production as per Mapping and configuration documents
o Replicating configuration across client environments using “Copy Config” tool o Providing PV expertise across Geographies based on Local and Global guidelines and facilitating business users in system implementation based on PV Regulations o Review of Data Migration and Validation Plan
o Change Management and Argus Safety end-user and Admin training Aditya Razdan – ************@*****.***
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o Setup of post release Change Management process
o Provide oversight to the QPPV for submission of ICSRs Validation Consultant
Support and Supervise end-to-end V-model Validation activities for upgrade and data migration projects of Oracle Argus Safety Enterprise suite of applications (including Argus J) for clients- Affymax, Alcon, Alexion, GSK, Mallinckrodt Pharmaceuticals (Ikaria), Novarits, Novo Nordisk, Ockham, Sanofi, Actavis (Warner Chilcott) and Allergan
o Authoring, reviewing and getting approval for all Validation deliverables- Plans, Strategies, test scripts, Defect tracking sheet and Validation Summary Report o Defining Validation scope, objectives, key deliverables, risks and resources o Creating, reviewing and getting approval for Requirement Tractability Matrix o Authoring, update, review and execution of all test scripts- IQ, OQ, PQ and MQ across environments- Development, Validation and Production o Ensure Defect lifecycle is followed by prioritizing and Triaging defects through Quality Center
(QC) or client followed tools and processes
o Getting closure and approval on deliverables by QA and client o Ensuring the validated system is audit compliant o Performing CAPA, quality risk analysis, internal and external audits o Assisting a Center Of Excellence in building best practices Technical Consultant
Business process redesigning for PRA involving replacement of the existing Axway Synchrony gateway with cost-effective Templar for transmission of E2B files from Argus Safety system to Regulatory authorities and Partners:
o Proof of Concept of Templar
o Installation of Templar across all environments (Development/ Validation and Production) o Authoring and executing IQ, OQ and PQ scripts
o Getting deliverables (IQs, OQs and PQs) reviewed and approved by client o Modification and validation of E2B Profiles to incorporate Regulatory authority (EMA and FDA) and Partner guidelines
o Performing E2B submission testing with EMA
o Post release support for unexpected issues
o Extended support for Multiple E2B data migration projects for product de-mergers Experience
Current Employment
• Senior Consultant with IQVIA (September 2014 – July 2018) Previous Employment
• Senior Consultant with Foresight Group LLC (October 2010- August 2014)
• Quality Analyst with Sapient Technologies (September 2009 – October 2010)
• Software Engineer with HCL Technologies Pvt. Limited. (July 2007 – September 2009) Education
Master of Computer Applications (M.C.A.) 2004-2007 Trainings and Certifications
• Validation and 21 CFR Part 11 Compliance of Computer Systems by Chinmoy Roy
• PRINCE2® Foundation (by EXIN – 5905197)
Aditya Razdan – ************@*****.***
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• PRINCE2® Practitioner (by EXIN – 5905203)
• PMP Certified (in progress)
• ITIL Foundation Certification
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