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Mr. Gautam brings almost 2 decades of professional experience to Nextrove, specializing in providing software solutions and services within the Life Science industry. With a deep understanding of the drug development process, particularly in safety and pharmacovigilance, he possesses a wealth of knowledge. His expertise encompasses all phases of the system design life cycle, focusing on strategic planning, business process optimization, global regulatory compliance, custom system design and development, as well as system implementation and integration. Prior to joining Nextrove, Pankaj held significant positions at IQVIA, Highpoint Solutions, November Research Group, and Oracle HSGBU (Relsys International). He is passionate about advancing human health and firmly believes in the intersection of health policy, business strategy, and innovation, which can deliver tremendous value.Domain - Life Sciences:• Proficient in the Pharmaceutical domain and regulatory compliance• Expertise in the Argus Safety Product Suite, including Safety, Console, Insight, Affiliate, Interchange, Reconciliation, and Dossier• Well-versed in Oracle AERS, ARISg, and custom software implementations• Understanding of Drug Safety (Pharmacovigilance) and Risk Management• Experience in implementing and delivering safety systems and risk management solutions• Knowledge of drug safety systems architecture, design, development, and integration with client environmentsTechnology:• Strong expertise in object-oriented design and programming using C# and .NET• Familiarity with web technologies such as ASP.NET, C#, C++, ASP, VB, WCF, and Ajax• Knowledge of Oracle database architectureSpecialties:• Pharmacovigilance business processes and technology• Implementation of safety systems• Integration of drug safety systems• Designing and configuring business workflows• Electronic submission and periodic submission• Enterprise architecture and design patterns• Proficiency in Microsoft technologies• Operational leadership• Effective team management to minimize attrition• Ensuring smooth transitions during acquisitions
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Co-Founder And Vice PresidentNextrove, LlcNoida, Up, In -
Co-Founder & Vice PresidentNextrove, Llc Jan 2019 - PresentNoida Area, IndiaNextrove is a distinguished global professional services firm that specializes in providing comprehensive support to Pharmaceutical and Biotech organizations. Our exclusive focus lies in offering a range of services, including PV, EQMS, RIM, Regulatory and Clinical Affairs, Salesforce, and Integration services. What sets us apart is our commitment to assisting clients in enhancing public and patient safety through preeminent and innovative solutions.Our team, spread across the US, Canada, Israel, and India, boasts an impressive average experience of 12+ years in PV, Regulatory, QA, EQMS, and MDM. Through our expertise, we have successfully guided numerous clients in meeting project timelines, achieving effectiveness, and attaining cost targets across various engagements.By combining our profound business knowledge with a strong technical skill-set, we excel in bridging the gap between business requirements and technology, consistently surpassing the expectations of our valued clients. -
Associate Director - Pharmacovigilance ServicesHighpoint Solutions Jan 2017 - Jan 2019Noida Area, IndiaHighPoint Solutions is a premier, global provider of specialized IT services exclusively serving Pharmaceutical and Healthcare organizations. With US offices in Philadelphia, New Jersey, Boston, Tampa, Irvine, San Francisco, and Chicago and international offices in Geneva, Zug, and Delhi, our team of 700+ consultants is strategically located to meet your needs through our laser focus on key industries, partners, and technologies. -
Senior Manager - Pharmacovigilance ServicesHighpoint Solutions Feb 2016 - Jan 2017Noida Area, India -
ManagerNovember Research Group Aug 2012 - Feb 2016Noida Area, IndiaNovember Research Group is a professional services company specializing in pharmacovigilance, dedicated to enhancing public and patient safety in the global Health Science industry. Our primary mission is to provide exceptional solutions that enable our clients to improve safety standards.In my role, I am responsible for leading and expanding a team at November Research Group focused on Clinical-Safety integrations and solutions. Our aim is to develop innovative approaches and establish seamless connections between clinical data and safety information. By leveraging our expertise in pharmacovigilance and clinical research, we facilitate comprehensive understanding of pharmaceutical product safety profiles, enabling effective risk management and enhanced patient care.Collaboration is a cornerstone of our approach, and we actively engage with stakeholders in the Health Science industry, including pharmaceutical companies, regulatory agencies, and healthcare providers. This ensures that our solutions align with their specific needs and regulatory requirements.Our team, driven by a commitment to excellence and continuous learning, stays at the forefront of emerging trends and utilizes the latest advancements in technology and data analytics to enhance safety monitoring in clinical settings. We strive to deliver tailored, robust solutions that drive improvements in patient safety and contribute to the advancement of global healthcare.At November Research Group, we aspire to be the trusted partner for pharmacovigilance and Clinical-Safety integrations. Through our dedication to delivering high-quality services and our passion for making a positive impact, we are actively working towards our goal of enhancing safety standards and driving positive change in the industry. -
Senior Lead ConsultantNovember Research Group Mar 2012 - Aug 2012Noida Area, India -
Principal Applications EngineerOracle Corporation Feb 2010 - Mar 2012Noida Area, IndiaDuring my tenure as the leader of the Argus Safety Development Team, my responsibilities included:• Collaborating with the project management team to analyze and clarify requirements.• Understanding the requirements and creating comprehensive technical design documents.• Designing and developing key features for the application.• Coding complex modules and conducting code reviews for requirements and issues.• Performing development testing and providing support for different modules of the Argus Safety Suite.Project:Project: Argus Multi-tenancyRole: Lead ProgrammerDescription:The Argus Safety Multi-tenancy Application aimed to enable multiple pharmaceutical clients of a Contract Research Organization (CRO) to exist as separate and distinct tenants within a single database. This architecture ensured complete segregation and restricted access to authorized users.Role:• Interacting with the project management team to analyze requirements effectively.• Involvement in proof-of-concept (POC) activities.• Creating the application's design.• Designing and developing key features, including the development and design of three out of four global screens.Environment:The project was developed using the following technologies:• ASP.NET 3.5• C#• XML• Visual Studio .NET 2008• JavaScript• HTMLAs the Lead Programmer, I played a crucial role in driving the success of the Argus Multi-tenancy project, ensuring effective communication with the project management team, contributing to the design, and delivering key features in alignment with the project goals. -
Senior Software EngineerRelsys India Pvt. Ltd. May 2006 - Feb 2010Noida Area, IndiaRelsys, which has now been acquired by Oracle Health Sciences GBU, is a renowned global provider of solutions for drug safety and pharmacovigilance.Responsibilities:Collaborate with the project management team to analyze requirementsComprehend the requirements and formulate technical designs accordinglyCreate and develop key featuresParticipate in proof of concept (POC) initiativesConduct code reviews for requirements and issuesProject: Argus Console JArgus J expands on the multi-language capabilities of Argus by enabling Argus Safety users to submit expedited reports to Japanese regulatory authorities. This web-based module incorporates Japanese-specific fields to meet the requirements of the Japanese market. Argus Console J is a web application used to configure the entire Argus J™ system.Utilizes a unified global database for managing safety information worldwideIncorporates Japanese dialogs for capturing Japan-specific case informationProvides Japanese translated code listsIntegrates an MedDRA browser and MedDRA J browserSupports the Japanese Drug DictionaryRole:Engage with the project management team to gather requirementsComprehend the requirements and develop technical designs accordinglyDesign and implement key featuresProject: Argus 5.0Argus Worklist was revamped using the new .Net framework and included significant functional enhancements.Key responsibilities undertaken on this project:Collaborate with the project management team to gather requirementsWork on complex modulesDesign and develop key featuresProject: Argus ConsoleArgus Console is a web application used to configure the entire Argus Safety™ system.Role:Interact with the project management team to gather requirementsUnderstand the existing applications and document themDesign Master list features using Factory and Builder patterns -
Senior Software Development EngineerHytechprofessionals Oct 2005 - May 2006Noida Area, IndiaProject: Interact Role: Lead ProgrammerDescription:Interact is a multithreaded interactive presentation tool where the user gets to create a presentation (much like PowerPoint). The application is built upon an open source application that offers wide range of functionalities. The project is to customize the existing tools and the functionalities offered by the application and add new tools and the functionalities. The project described is rewriting existing functionality from the ground up in C# and adding new features to Interact.Role:• Interact with the Client to gather requirements. • Understand the existing applications and create documents on that• Designed and developed the key features.Environment: C#, XML Visual Studio .net, Win form (Window Application with GDI+) -
Software EngineerMindfire Solutions Dec 2004 - Oct 2005New Delhi Area, IndiaProject: Medappz (Electronic Medical Record)Role: ProgrammerDescription:Medappz has created an electronic medical record and medical office management system that empowers ambulatory care providers with the necessary tools to automate medical records and facilitate connectivity between trading partners through advanced internet technologies. By utilizing data-based EMR software, Medappz is revolutionizing the way ambulatory care providers capture, manage, and exchange patient information. The critical process of utilizing medical record data to make life-saving decisions must be conducted within an environment equipped with appropriate technology for effective analysis and maintenance.Key responsibilities undertaken by me in this project include:Analyzing requirements and designing the databaseProviding valuable insights and generating key ideas for the teamDeveloping the presentation layer to facilitate interaction with the business layerImplementing key features within the business layerEnvironment: C#, ASP.NET 1.1, JavaScript, SQL Server 2000 -
Graduate Engineer TraineeReliance Industries Limited Jul 2003 - Nov 2004Punjab, IndiaAs a Graduate Engineer Trainee (GET) at Reliance Industries' Hoshiarpur Polyester Unit, I went through a comprehensive training program designed to provide the necessary skills and knowledge to excel in the field of engineering. This program offered me valuable hands-on experience and exposure to various aspects of the polyester manufacturing process. I worked under the guidance of experienced professionals and contributed to the efficient and safe operation of the unit.
Pankaj Gautam Skills
Pankaj Gautam Education Details
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Science -
Ptps High School
Frequently Asked Questions about Pankaj Gautam
What company does Pankaj Gautam work for?
Pankaj Gautam works for Nextrove, Llc
What is Pankaj Gautam's role at the current company?
Pankaj Gautam's current role is Co-founder and Vice President.
What is Pankaj Gautam's email address?
Pankaj Gautam's email address is pa****@****ons.com
What schools did Pankaj Gautam attend?
Pankaj Gautam attended Indian Institute Of Technology, Delhi, St. Xavier's College, Ranchi, Ptps High School.
What skills is Pankaj Gautam known for?
Pankaj Gautam has skills like C#, Requirements Analysis, Pl/sql, Asp.net, Design Patterns, Oracle, Argus Safety, Pharmacovigilance, Integration, 21 Cfr Part 11, Architecture, Solution Architecture.
Who are Pankaj Gautam's colleagues?
Pankaj Gautam's colleagues are Shubham Tiwari, Ayush Gautam, Aparna Cherukuri, Muralikrishna Muthuswamy Ramasamy, Deepthi Palai, Nandakumar Dn, Manoj Kumar S.
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