Saket Singh

About Saket Singh

Proficient in end-to-end Lift and Shift operations, including full-scale migrations, implementation, and customization, with a strong emphasis on data transformation and E2B enhancements. Experienced in Axway/B2B configuration, OBIEE analytics, and providing comprehensive support services encompassing database management and system optimization.Industry Expertise:• Pharmacovigilance/Life sciences• Well versed with Pharma Domain and Regulatory Compliance• Argus Safety Product Suite• Development and integration with client environments• ITFunctional Expertise: • Oracle Argus Safety- Upgrade/Installation/Implementation (8.4.4/8.4.3/8.4.2/8.4.1/8.x/7.x) • Oracle Argus database upgrade• Argus Data Migration and LiftNShifts• Argus Safety Data Transformation• Customizations like Workflow, Advance conditions, Case Priority, Letter Template, Placeholders, Post save, Data correction, Code list, Reporting Rules, Reporting Destination, Function, Procedures etc.• E2B(R2/R3) Customization including FDA E2B (R3) FAERS profile• E2B (R2/R3) import as a part of migration activity• Duplicate data correction• Gateway (Axway/ Oracle B2Bi) Installation and Configurations• Data Extract (Client Specific)• Migrated profiles to made compliant to new features in Argus 8.4.4/8.4.3/8.4.2/8.4.1/8.x/7.x• Argus Safety maintenance and Technical Support• Regulatory Submissions, Compliance and fixing issues related to failure• Access Management• Argus System/ Business Configuration- Testing and validating the changes request/ control Codelists/ Products/ Studies maintenance• Argus analytics and OBIEE Report development• Admin training, User training, Workshop, CRP on Argus 8.4.4/8.4.3/8.4.2/8.4.1/8.x• MedDRA and WHO Drug dictionary recode and upload• Document relates to all these activities (IQ, IQP, Impact Assessment, OQ, PQ, FRA, URS, DUP. etc.)

Experience

1. Principal Consultant

   Oracle

   Dec 2023 — Present · Bengaluru, IN

   Proficient in LiftNShifts, covering migration, new implementations, and data transformation customization in Life Sciences.• Specializes in gateway configuration, using Axway and Oracle B2B for seamless integration.• Extensive expertise in Pharmacovigilance regulations, ensuring compliance in projects.• Expert in Argus Safety Suite, including installation, implementation (8.4.1/8.4.2), migration, and upgrades.• Skilled in Oracle Argus database management for operational efficiency.• Capable of developing tailored solutions, including pre-save and post-save functions.• Proficient in customizing Argus Safety workflows, conditions, and letter templates.• Experienced in E2B customization for specific reporting needs.• Ensures compliance with Argus 8.4.x features during profile and data migration.• Familiar with exporting/importing data for efficient database management.• Provided training sessions for Argus Admin, User functionalities, and workshops including CRP.• Skilled in Argus analytics and OBIEE.

Education

• MDU Rohtak

  Bachelor of Technology (BTech), Computer Software Engineering

  2007 — 2011

• Chinmaya Vidyalaya

  Higher Secondary-XII, Science

  2003 — 2005

• ITBS

  Oracle Certification, Oracle

  2011 — 2012

• Chinmaya Vidyalaya

  Secondary-X, General

  1991 — 2003