Ritesh Kumar Email & Phone Number

Having an experience in all phases of design, development, and implementation of safety data migration, product development and support functions for multiple pharmaceutical companies. Having hands-on experience of working on various product versions of Argus Safety Suite, PMDA R2 to R3 and EMA R3 to R2 implementation. Possess good communication skill, analytical ability, and presentation skills.• Strong Experience in identifying, analyzing and translating business requirements into solutions• Extensive experience of E2b Customization based on different profile e.g. PMDA, FDA, and EU.• Knowledge of E2b R3 guidelines for PMDA and EMA.• Implementation and Up-Gradation of the Argus Safety system for large pharmaceutical companies.• Experience of Argus Support with multiple Pharma clients.• Assess business requirements and provide technical solutions for the same which cannot be met with out of the box Argus Safety Suite. • Owned PMDA E2b customization for leading pharma companies. • Knowledge of Japanese pharma regulations viz PMDA.• Having excellent knowledge of the Drug safety domain and regulatory compliance.• Knowledge of 21 CFR, part 11.• Provides Professional training on Pharmacovigilance and Argus Safety Suite.• Experience in Meddra upgrade, MedDRA re-coding, Database upgrade, WHO Drug recoding, Local Affiliate configuration and Integration with Argus.• Well versed with various phases of software development life cycle. • Hands on Experience on different modules e.g. Argus, Argus J, ESM, AG services etc.

Listed skills include Sql, Oracle, Pl/Sql, Unix Shell Scripting, and 12 others.