02/13/2026 updated
100 % available
Pharmacovigilance Systems Consultant | Argus Safety & E2B R3 Specialist
Uttar Pradesh, India
Worldwide
Master in Pharmacology from DIPSAR, New Delhi (2008)About me
Pharmacovigilance & Argus Safety Consultant with 15+ years of experience in drug safety, FDA E2B R3 implementation, Argus 8.x upgrades and regulatory compliance (FDA, EMA, PMDA, TGA). PSM II certified. Expertise in Argus business configuration, L2/L3 support, validation (IQ/OQ/PQ), gateway testing
Data AnalysisBug ManagementCustomer Relationship ManagementBusiness AnalysisBusiness Process MappingComplianceSystem ConfigurationConsultingPharmacovigilanceElectronicsFunctional TestingIntravenous PyelogramManual TestingProject ManagementMedDRA
Drug Safety and Pharmacovigilance
Expertise in Argus Safety 8.4.1, Argus Safety Japan, Argus Console, Electronic Service Manager (ESM), Axway, ARISg, HP ALM, Oracle SQL Developer, and IVP collect and IVP Intake systems
Regulatory Compliance
Proficiency in E2B R2 and R3 Profile, FDA E2B R3 Implementation, TGA R2 Implementation, FDA, EMA, PMDA Regulatory knowledge, and compliance management
Business Analysis and Consulting
Experience in business process analysis, requirements specifications, data analysis, technical guidance, and client engagement across US, Europe and Japan markets
Database Management
PLSQL (Basic) skills and Oracle SQL Developer experience
Argus System Configuration
Dictionary upgrades (MedDRA, Japan DD, WHO DD), Argus Console Configurations, Reporting Rule and Products and Licenses Harmonization, Impact Analysis
Manual Testing
ALM testing including reviewing test scenarios, functional testing, test and optimize systems, defect management, bug fixes, Requirements Traceability Matrix (RTM)
Training and Development
Training delivery for more than 50 people on Pharmacovigilance and Argus Safety
Project Management
SOW and project estimations, CRP management, and client site consulting experience
Expertise in Argus Safety 8.4.1, Argus Safety Japan, Argus Console, Electronic Service Manager (ESM), Axway, ARISg, HP ALM, Oracle SQL Developer, and IVP collect and IVP Intake systems
Regulatory Compliance
Proficiency in E2B R2 and R3 Profile, FDA E2B R3 Implementation, TGA R2 Implementation, FDA, EMA, PMDA Regulatory knowledge, and compliance management
Business Analysis and Consulting
Experience in business process analysis, requirements specifications, data analysis, technical guidance, and client engagement across US, Europe and Japan markets
Database Management
PLSQL (Basic) skills and Oracle SQL Developer experience
Argus System Configuration
Dictionary upgrades (MedDRA, Japan DD, WHO DD), Argus Console Configurations, Reporting Rule and Products and Licenses Harmonization, Impact Analysis
Manual Testing
ALM testing including reviewing test scenarios, functional testing, test and optimize systems, defect management, bug fixes, Requirements Traceability Matrix (RTM)
Training and Development
Training delivery for more than 50 people on Pharmacovigilance and Argus Safety
Project Management
SOW and project estimations, CRP management, and client site consulting experience
Experience
Professional experience10+ years
Freelancer since2026
Languages
EnglishFluent
Project history
Handled end to end Argus upgrade project (Argus 8.1.1 to 8.4.1) in the capacity of BA/Business Consultant. FDA E2B R3 and TGA R2 Implementation for 3 clients. UFRS creation and Argus configuration updates. Around 400 Reporting Rule, Products and Licenses configuration and Harmonization. Code list configuration for Argus. Autolistedness post save solutioning. Data center Lift and Shift. Requirements Specifications and detailing. IQ, PQ and OQ drafting and execution. Conducted CRP in Osaka, Japan.
L2 and L3 support (Argus Safety) for a renowned Japanese customer. Provided Application and Configuration for managing deployment in Argus application. Oversee Change Request Implementation and Impact Analysis. An experience of business consultancy onsite for 6 Months in Japan as a Technical and Functional Oracle Argus consultant. Defining process improvement steps in the ongoing projects and reducing the TAT. Interacting with clients to assess business requirements and determine software needs. Provided Manual testing services as Validation and ARGUS SME to renowned American Customer.
Manage daily workload for individual case processing, literature searches, PSUR generation and any other tasks relevant to the Pharmacovigilance Department. Quality Check of ICSRs in APCER's pharmacovigilance database (ARISg). Management of Compliance with the Company Standard Operating Procedures and regulatory requirements. Liaise effectively and maintain excellent relationship with the clients and internal/external contacts.