Arun Janapala

Experience

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  St. Paul Travelers

  Feb 2004 - May 2006

  QA Analyst

  As a QA Lead for St Paul Travelers, was involved in testing the CPP lines of business (General Liability, Deluxe, Crime, Inland Marine, Property and Multi Line) which can be accessed via a Web-enabled policy rating application

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  Biogen

  Jun 2006 - Oct 2010

  Team Lead - TrackWise (Quality Management Solution) Team

  Responsible for configuration and implementation of various Quality workflows such as Lab Exceptions, Global Change Control, External Audit, Regulatory Inspections, Clinical Study Audits and Internal Audits within TrackWise.Lead the implementation of joint effort between Global Quality, Global Operations, Regulatory Affairs and IT to ensure Regulatory and QA compliance of Commercial Product Ship release in global markets.

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  Philips Healthcare

  Oct 2010 - Nov 2012

  Trackwise Configuration Lead

  System Analyst responsible for configuration and implementation of Medical Device Complaint Handling and AE reporting In TrackWise.

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  November Research Group

  Nov 2012 - Sept 2015

  Principal Consultant

  Lead Data migration effort from AERS to Argus for a Tier 1 Canadian Pharma.Lead Data migration effort to migrate Product Complaint from AERS to TrackWise for a Major US based Biotech company

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  Foresight Group International AG

  Oct 2015 - Jan 2018

  Senior Principal Consultant

  Lead the data migration activity for a German Pharma Major, with their implementation of Argus Safety J V8.0 and consolidation of the Local J-safety system (Perceive) with Argus. Oversee and assist in leading the Custom Development practice (Data Migration, Custom Reporting and Interfaces to Safety systems ) at FGI. Other key responsibilities include, RFP and SOW authoring, Capacity planning, Hiring and trainings and monitoring the health of projects across the portfolio.

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  Genpact

  Feb 2018 - Apr 2020

  Solution Delivery Lead

  Solution Delivery lead. Implement AI enabled PV SaaS solution that automated Safety Case Intake at one of the Top 3 Pharma. Primary Interface between the Client and Product Engineering Team. Lead the COTS implementation activities on Client SDLC including Data Migration, Custom Reports, Interface to Argus Safety

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  IQVIA

  Apr 2020 - Dec 2021

  Principal - Consulting Services

  Manage large team of consulting resources globally, their Utilization and Allocation across consulting portfolio. Lead resource skill readiness initiative for new inhouse Drug Safety Platform, development of implementation methodologies and accelerators, metrics and governance. Lead key implementation projects including introduction of Vigilance platform to a large Japanese Pharma, Solution design and implementation of Brexit regulatory changes and FDA eMDR regulatory changes across various clients. Show less

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  Genpact

  Dec 2021 - May 2023

  Offering Lead (PVAI)

  Aligning, connecting designs, functional requirements, non-functional specifications to business & product strategy, roadmaps, ensuring vital regulatory, compliance regulations are adhered to, managing entire life cycle of product from initial early adoption through securing market leadership. Outline the value proposition and go-to-market strategy for respective modules.

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  Ultragenic Research and Technologies

  May 2023 - now

  Senior Director

  Ultragenic brings together Life sciences domain expertise, Third party system knowledge and Deep technology to develop well-defined solutions, which address challenges across the Pharmacovigilance function. Our solutions are agile, flexible and scalable, developed using advance technologies such as AI, Machine learning and Robotic process automation that enable us to serve large and small organizations, both in developed and emerging markets. With rich experience in engineering and deploying best-in-class life sciences solutions, our team is well placed to help achieve your goals. Show less