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
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Interests
Cricket, Hangout with friends, farming
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
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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
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