Merck KGaA

Expert Veeva Vault RIM

Posted On

May 26, 2025

Location

Bangalore, Karnataka

Experience Level

E - Professional (10+ years)

Job Type

Full-time

Apply By

June 17, 2025

Job Description

You will take an important role in enhancing and updating Veeva Vault RIM for Regulatory Quality and Safety operations. As the key stakeholder, you will manage the operations of Veeva Vault RIM, focusing on data processing, data quality frameworks, and data governance also while also playing a key role in rolling out automation projects using next-generation AI and other tools..Who You Are: Basic/ Minimum Qualifications:· Masters in a Life Science, Medical, PharmD or related discipline (minimum M.Pharm/MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)· 8-10 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role. Minimum 6 years of Regulatory affairs/ Operations experience Preferred Requirements:· Drive and Lead Regulatory Data Quality initiatives and supports definition of data entry guidance· Drive compliance activities in VEEVA Vault· Demonstrate expertise in training and documentation creation as per data entry guidance and system functionalities in VEEVA Vault· Champion Data Quality Monitoring by conducting thorough and regular monitoring of data quality metrics to ensure adherence to defined standards· Collaborate effectively with Global Regulatory Affairs and other functions, departments and divisions to foster process and data quality topics as well as IDMP related topics· Demonstrate strong expertise in driving data cleansing activities related to data quality initiatives· Champion support, training, and end user communication for data management topics· Enable data literacy among users directly or indirectly and contribute to change management & Data Governance among stakeholders· Drive & lead the development and delivery of training materials· Accountable for clear communication to all stakeholders· Accountable for VEEVA RIM Change Management & Communication activities· Accountable for update & quality check of regulatory activities/update requests related to plan, product license maintenance, strategy execution and operations for regional and local products closely aligned with the HQ Global Regulatory Therapeutic Areas· Drive and Lead Automation Activities.· Overview of IDMP data management activities - like P, O and R data management & Data Catalogue

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