Senior Manager-RIMS
Genpact
5 - 10 years
Mumbai
Posted: 3/5/2025
Job Description
Responsibilities
Lead IDMP Implementation project lead the definition & implementation of IDMP Data Catalogue (including DADI mapping), data quality assessment, authoritative source mapping and is currently supporting the establishment of data governance responsibilities across critical IDMP data points.
Supportdata & content migration into Regulatory Information management system.
Recommend data standards for new RIMS and data migration projects.
Contribute to the RIM and IDMP Centre Of Excellence team, keeping abreast of the latest Industry trends and sharing knowledge with colleagues to improve overall performance.
Maintain up to date knowledge of the organization services and Industry trends and best practices to create compelling proposals that addressed client needs and requirements.
Translate business needs into technical requirements and configurations to implement regulatory systems.
Maintain user requirements and traceability as they evolve with ongoing system implementations.
Author, review, and execute the User Acceptance Test (UAT) scripts for validation of clients RIM System.
Work on Identifying and extract data from different source repositories to analyze and consolidate into spreadsheets for migration field and value mapping.
Advised on system troubleshooting, leveraging deep understanding of modules, configurations, and data management activities for Regulatory systems (RIM, Publishing and other systems used for Regulatory operations)
Author and update Standard Operating Procedures for new processes.
Subject Matter Expert for xEVMPD & IDMP
Define processes for xEVMPD and IDMP data management in regulatory systems (RIMS and Eudravigilance tools (EMA))
Maintain up-to-date knowledge on latest IDMP guidance to support internal and external thought leadership initiatives.
Perform IDMP data assessment, gap analysis and verification of data extracted from structured and unstructured sources through NLP (Natural Language Processing) tools.
Member of Center of Excellence (COE) team responsible for managing clients from pharmaceutical companies with services covering for areas of RIMS, XEVMPD, IDMP & Publishing
Prepare OQs, UAT Test Scripts and Functional Specification Documents for various business processes.
Define business processes and end to end testing of functionalities in LSRIMS system for major pharmaceutical Client.
Provide System demos to the client business teams and organized workshops to gather business requirements.
Deliver trainings and involved in developing of e-learning content for the RIMS Training project.
Responsible for efficient management of tasks (Life cycle management, Publishing, Submission, and other RA activities)
Handle data migration projects including setting of business rules and source data identification methods.
Manage setup and maintenance of local SOP system describing all procedures and processes to ensure compliance.
Provide SME consultation for xEVMPD Submission for EU that involved process definition, training, and data management activities.
Provide functional SME support to the Regulatory product development departments.
Deliver onsite trainings to clients on the REGISTER and LSRIM systems.
Lead validation activities including preparation and execution of OQ, PQ and UAT support to customers.
Organize customer workshops on business processes, configuration, and security model.
Member of task force team for the development of Regulatory and eCTD tools
Understanding and in-depth familiarity with ISO IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239, ISO 11240) for the interpretation of product information available in the dossier.
Maintain Drug Product portfolio(s) and submission of XEVMPD cases with project and vendor management.
Maintain Drug product information for products.
Prepare and performed XEVMPD data submission to EMA authorities.
Maintain Registration information for Glenmark across all regions for global products.
Project Manage Regulatory business operational projects.
Manage data migration initiatives, user acceptance testing (UAT)
Review validation related documents (IQ, OQ, PQ) for implementation/upgrade of software projects.
Facilitate training for Regulatory Affairs and Pharmacovigilance stakeholders.
Perform vendor management, budget management, negotiations with vendors and review of agreements.
Participate in regulatory compliance projects including Quality management system using SAP software.
Maintain trackers related to audits (in house and vendor CAPA trackers).
Prepare, reviewed, and submitted high-quality CMC dossiers for EU.
Prepare and reviewed Risk Management Plans in accordance with new pharmacovigilance legislation and communication with GPVD department.
Prepare and update Nonclinical & Clinical Overviews in compliance with new EU regulatory requirements.
Update approved data and maintenance of XEVMPD database while monitoring and supporting the implementation of regulation and requirements for regulatory submissions.
Compile and reviewed Module 5 documents (Bioequivalence reports)
Prepare SPCs, labelling and Package leaflets as per QRD for different type of applications (MRP, DCP, National).
Prepare Mockups (labels) for EU-Module-I, in various EU languages for National/MRP/DCP submissions as per Blue box and/or country specific requirements
Prepare Patient Information Leaflets for the Readability Test according to Readability guidelines
Prepare Bridging statements/ Reports to waive the Readability test report on the PILs.
Prepare dossiers in eCTD, NeeS & other EU required electronic submissions (Germany, Portugal, UK etc).
Prepare and submit variations and variation notifications through MHRA Portal
Prepare Company Core Data Sheets for Renewals (CCDS) in accordance with Company Core safety Information (CCSI) for Renewal & Variation applications
Manage correspondence with regulatory authorities during the review process to ensure submission approval.
Perform product life cycle management & maintenance of filings database.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle.
Evaluate change controls for level of change and consequent regulatory notification.
Ensure compliance with product post-marketing requirements.
Ensure implementation of updated labelling information in the commercial phase of medicinal products
About Company
Genpact is a global professional services firm that offers a wide range of digital transformation services and solutions. With a presence in over 30 countries, Genpact leverages its deep domain expertise in operations and analytics to help businesses transform their operations, improve efficiency, and enhance customer experience. The company combines digital technology, data science, and operational excellence to deliver business outcomes across various industries, including banking, insurance, manufacturing, and healthcare. Founded in 1997 as a subsidiary of GE, Genpact has grown into an independent, NYSE-listed company with a diverse workforce of over 90,000 employees globally.
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