Experience

• 

  Confederation of indian industry

  Aug 2012 - Nov 2012

  Project assistant
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  Tata consultancy services, boehringer ingelheim

  Jan 2013 - Aug 2015

  Validation engineer

  • Validated Oracle Clinical (OC) for Boehringer Ingelheim pharma which is a database management system designed by Oracle to support Clinical Trial operations. It provides data management, Thesaurus management for medical coding of verbatim terms, Batch data loading and extracting capabilities, data entry, and data validation functionalities• Understood and gathered requirements from study business users (like TDMs, Investigators, CRAs). Tools proficient into: IBM Rational DOORs• Analysed and documented the client's requirements by interacting with key business stakeholders and designing L4 business process maps under medicine area• Performed test management activities such as the creation of Test plans/Test scripts (OQs/PQs), defect logging (JIRA), test admin reviews, providing estimations for work requests• Trained the new associates regarding the application and processes in the team.• Ensured all the processes for a work order are completed as per the set standards and compliance. Show less

• 

  Foresight, an iqvia company

  Aug 2015 - Aug 2019

  Pv senior consultant

  • Validated drug safety systems (ARGUS & ARGUS-J) and regulatory interfaces for 12 Tier 1 & Tier 2 Pharma Companies in accordance with CSV, GxP & GAMP 5 methodologies by considering 21 CFR Part 11 & EU Annex 11 regulations• Managed, configured, and customized the drug safety systems for 8 Tier 1 Pharma Companies as per the regulatory requirements, process efficiencies, and several SDEA agreements with the partners• Managed end to end configuration/customization of the system (Global & Japan) that includes but not limited to case processing workflows, ICSR E2B R2/R3 customizations, maintenance of company's PLS (product-licenses-studies) configuration, set up of expedited reporting rules in accordance with HA regulations, SDEA partner agreements, etc., ICSR validations, Edit checks, periodic & aggregate reports• Actively participated and contributed to many drug safety systems workshop to capture the client-specific & regulatory requirements and demonstrated the built system in the conference room pilots• Developed and maintained the configuration baseline documents to store and version control the company's drug safety data that resides in drug safety systems• Validated the IT drug safety systems by following CSV practices (V-Model) and created regulated documents that includes but not limited to GxP assessments, Val & Test plan, Design Documents, URS, FRS, RTM, IQs, OQs, PQs, change management, defect tracking, Val summary reports, system release certificate, etc. Show less

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  Elite safety sciences

  Aug 2019 - Oct 2020

  Principal consultant in it pharmacovigilance & drug safety systems

  • Configuring and customizing the global drug safety systems for a US-based pharma company as per the regulatory reporting requirements, process efficiencies, and several SDEA agreements with the partners• Collaborating with the Global PV Head and relevant stakeholders to ensure the drug safety systems & related interfaces to be always compliant with the latest regulations and agreements• Working directly with the business users to understand the current challenges, optimizing the workflows, providing cost-effective solutions and controlling the systems via change management to be always audit and inspection ready• Supporting the Pharma company from an IT standpoint in upgrading the Argus safety system and supporting & managing the managed services team by acting as a liaison between vendors• Supporting a team of 70 case processing users to ensure seamless and timely submission of the expedited & periodic reports to the Health Authorities, Safety Affiliates, LPs, ECs etc. Show less

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  Pinnaxis

  Nov 2020 - now

  • Senior Principal Consultant

    Apr 2022 - now

  • Principal

    Nov 2020 - Mar 2022