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KANKANALA SAINATH REDDY
Argus Support Engineer
Hyderabad
Summary
Skilled Consultant skilled in client oversight, issue resolution and business presentation. Impressive capability for juggling multiple tasks and projects within deadlines and delivering quality suggestions. Focused on helping resolve business issues and capitalize on development opportunities.
Overview
8
8
years of professional experience
6
6
years of post-secondary education
1
1
Language
Work History
Consultant
IQVIA RDS India Pvt Ltd
Hyderabad
04.2022 - Current
- Maintenance of Drug Safety Application (Argus) Working knowledge of writing SQL queries and PL/SQL code
- Provide application configuration expertise on Adverse Event Reporting product (Argus Safety)
- Requirements Analysis
- Development and accountability of document deliverables (Requirement Documents CBD/CCs/ UTSX/ CDRV
- Design, build and implement configuration for clients
- Conduct POCs to understand the effectiveness of the solution and incorporate feedback into the solution
- Closely work with clients to support implementation and resolve issues
- Implement Quality measures to drive operational efficiencies and articulate the value to the customer
- Good knowledge of Drug Safety and Pharmacovigilance processes and regulations
- Participates or leads teams in the design, development and delivery of consulting projects or components of larger, complex projects
- Reviews and analyzes client requirements or problems and assists in the development of proposals of cost effective solutions that ensure profitability and high client satisfaction
- Designs, structures and delivers client reports and presentations that are appropriate to the characteristics or needs of the audience
- Recommends improvements and alternative solutions to resolve problems
- Well versed with various SDLC models, Software Test life cycle and Defect Management Life Cycle
- Perform user administration and configuration activities
- Hands-on with business and system configuration of safety solution
- Experience in implementation and support of safety system at CRO
- Logical thinking and problem solving skills along with an ability to collaborate
- Good understanding of user acceptance testing (UAT) and support in UAT executions
Clinical Systems Administrator
Novotech Clinical Research India PVT LTD
Bangalore
03.2020 - 04.2022
- Maintenance of Drug Safety Application (Argus) Working knowledge of writing SQL queries and PL/SQL code
- New Study setup in Argus as per the requriment
- Provide application configuration expertise in Argus Safety, Siebel CTMS, Sureclinical eTMF
- Requirements Analysis
- Conduct POCs to understand the effectiveness of the solution and incorporate feedback into the solution
- Good knowledge of Drug Safety and Pharmacovigilance, Clinical Research and Document Management processes and regulations
- Well versed with various SDLC models, Software Test life cycle and Defect Management Life Cycle
- Perform user administration and configuration activities
- Experience in support of safety system, clinical and document management system at CRO
- Logical thinking and problem solving skills along with an ability to collaborate
- Good understanding of user acceptance testing (UAT) and support in UAT executions
- New site, region set up in CTMS and eTMF
- New study set up in CTMS and eTMF
- New contacts addition in CTMS and eTMF
- Helping the users to update SSV, SIV dates
- Study Archival in CTMS and eTMF
- Liaison for project teams for non-technical CTMS questions
- Conduct of general and project-specific CTMS training
Senior Engineer - Application Support
Aris Global India PVT LTD
Mysore
07.2019 - 03.2020
- To assist post-sales support and solutions to the ArisGlobal customer base while serving as an advocate for customer need. This involves inquiries via phone and electronic means
- To address the customers on technical questions regarding the use of and troubleshooting of our products (Aris G, LSSMT, and ESM)
- To be a point of contact for customers/regional stakeholders of ArisGlobal/regional deployment leads
- To be responsible for facilitating professional relationships with customer, support and providing advice / assistance to internal ArisGlobal employees on diverse customer/deployment situations and escalated issues
- To work on customer specific or product specific or internal function specific end to end product deployments
- Analyze the issues by simulating in lower environments and provided resolution to the customer
- Verify logs and escalating the issue to code review team and development team and following up for permanent fix
- Provide the work around to the customers to ensure the business is continued smoothly till the permanent fix is provided
- Generate SAE/AE reconciliation by writing SQL scripts
- Handle multiple customers in weekly call and answering questions raised by them
- Conducted tests to determine success of product performance.
- Managed project documents, blueprints and specifications.
- Generate aggregate (PSUR, PBRER, PADER) reports using aghub application.
- Adhered to timelines to meet quality assurance targets.
- Mentored and coached entry-level and junior engineers to improve talent and boost skill levels.
Global Safety and Pharmacovigilance Associate II
Syneos Health
Hyderabad
11.2016 - 02.2019
- Performed book in activity of the cases which received through different routes
- Coding of adverse events using MedDRA dictionary
- Performed full data entry of the cases including narrative writing, causality, and labeling assessment
- Performed quality review of the cases and sending instant feedback to the data entry user
- Distributing the cases to different partners depends on distribution contacts
- Performed electronic submission of the cases to FDA and EMA
- Downloading the cases from EMA portal
- Performing submission activities of the cases
- Verification of ACKs and identification of case data issue and re-processing of cases after correction
- Co-Ordinate with vendor support for Argus for open issues
- Involved in UAT
Senior Process Associate
Tata Consultancy Services
Mumbai, Pune
05.2014 - 10.2016
- Administered the entry and revision of applicable information into the Aris G database for initial or follow-up reports
- Accepted cases submitted via E2B as applicable
- Updated and entered appropriate data into Aris G database and ensured data was captured according to client SOPs
- Ensured accuracy of coding, which includes selecting appropriate event terms in MedDRA and worked closely with the physicians
- Wrote narratives summarizing the events according to client SOPs for spontaneous, clinical, and literature cases through assessment of all source documents
- Communicated closely with clinical investigators to ensure accuracy of data, which included generating and resolving queries
- Performed quality review and checking cases for discrepancies for any errors
- Responsible for submission of the cases.
Education
Master of Science - M. Pharmacy (Pharmacology)
Vaagdevi College of Pharmacy
Warangal 11.2011 - 03.2014
B.Pharmacy - Pharmacy
Jyothismathi College of Pharmacy
03.2007 - 03.2011
Skills
Strong pharmacovigilance knowledge in end to case processing
Good knowledge in ARUS
Good knowledge in SQL and medium knowledge in PL\SQL
Base SAS V9 certifiedGood knowledge in drug regulatory guidelines
Configuration management
Project Management
User support
Client Relationships
Product Life Cycle Management
Interests
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
There is a powerful driving force inside every human being that, once unleashed, can make any vision, dream, or desire a reality.
Tony Robbins
Timeline
Consultant
IQVIA RDS India Pvt Ltd
04.2022 - Current
Clinical Systems Administrator
Novotech Clinical Research India PVT LTD
03.2020 - 04.2022
Senior Engineer - Application Support
Aris Global India PVT LTD
07.2019 - 03.2020
Global Safety and Pharmacovigilance Associate II
Syneos Health
11.2016 - 02.2019
Senior Process Associate
Tata Consultancy Services
05.2014 - 10.2016
Master of Science - M. Pharmacy (Pharmacology)
Vaagdevi College of Pharmacy
11.2011 - 03.2014
B.Pharmacy - Pharmacy
Jyothismathi College of Pharmacy
03.2007 - 03.2011