Raj Kumar Edem Email & Phone Number

Hyderabad, In

India

Project Requirements on Pharmacovigilance Reports.Development of PADER, PBRER Reports through SQL, Business Objects.Resource Management for project deliverables for different client requirements.Design database structure for Reporting. Customize database fields for Reports.Knowledge on ARISg, LSMV application,Submission of E2B Files with R3

Mysuru Area, India

• Manage ARISg products with different departments related to issues, fixes.• Responsible for quality, workload management of all global customers request.• Manage products of ARIS Global (Regulatory, Safety).

Hyderabad Area, India

• Generate reports through SQL, PLSQL from ARGUS safety Database• Manage PVDM team in generating reports and Client audits.• Provide PSUR, DSUR Report from Database.• Maintaining team workload and quality monitoring.• Point of contact for client and end users for any deliverables.

Benguluru

• Support on Drug Safety system with Business and Technical perspective.• Providing assistances on E2B Submissions, Gateway setup, R3 Support.• Customize workflow of ARISg.• Customize E2B tags in ARISg, create new E2B Tags based on business requirements.• Auto case processing into ARISg workflow, Distributing to Health Authorities, Partners.• Supporting on ARISg, agXchange application.• Generating reports through oracle DB using SQL, PLSQL.

India

Working for Life science and provide assistance on Business requirements.- Involvement with Research and Development team, NDA(New Drug Application), IND(Investigation New Drug) .- Marketing research on Supply chain Management in Life science.- Capabilities with Phase IV clinical trials reporting.- Providing training on ARISg application.

India

• Domain Knowledge on Pharmacovigilance (ICH ICSR) and does Business Analyst role for project setup.• Setup Gateway submission (AS1, AS2) as per the Regulatory Authorities (EMA, FDA, BFARM, Health Canada) with Test cases. • Understanding functional process from Business people and correlating with ARISg products to configure accurately. Analyzing requirements, verification and validation of the compatibility.• Work Experience at client place and collecting requirements, explaining the functionality and understanding the Business Process.• Executing PLSQL Scripts, modifying existing packages, procedure.

India

- Providing Technical and Functional Support on ARISg Application.- Strong skills in Life science of Pharmacovigilance with Safety system and Triaging of cases.- Provide guidance in submitting ICSR cases to Authority, Partners.- Specialized in Pharmacovigilance Business Process, Requirements, Regulatory Compliance.

India

- Providing Technical and Functional Support on ARISg Application/Product.- Implement/Validation/Testing of new Product changes as per the customer requirements on ARISG Application.- Involve with Project Group in collecting Business requirements from client.- Good with electronic Distribution setup (for EMA, FDA, MHRA and trading partners).- Interacting with clients on timely basics with relates to Issues and upgrades of products.- Upgrade WHO, MedDRA dictionaries.- Possess knowledge in Installation, configuration of ARISg product and other related applications of safety system .

India

- Worked under WPM Operations with ID Management.- Coordinating with Forecasting & Scheduling analysts- Creating schedules according to the operations.- Managing Employees hierarchy.- ID creation and updating PeopleSoft based on Employee profiles.