Prashanth Kumar
IT Validation and Compliance Specialist
Bengaluru
Summary
I have a total of 10+ Years of Experience in PHARMACOVIGILANCE, HEALTHCARE Domain in ARGUS SAFETY. I am looking for a career where I can learn without limits and where my skills and abilities would be transformed into substantial results for the organization and build my career in a way that would allow to develop of my skills and to seek a challenging position.
Overview
1825
1825
years of professional experience
2012
2012
years of post-secondary education
Work History
IT Validation and Compliance Specialist
Novonordisk
Bengaluru
06.2021 - Current
- Served as Incident & Problem Manager to effectively manage the incident and problem management process for assigned Safety system
- Served as a Change & Release Manager to support system releases and Validation Responsible role
- Handling change requests to comply with the Change Management work instruction
- Validation Activities: Participate in Annual Periodic reviews (user review report, configuration review report, IT periodic system evaluation) Support the system during internal and external audits
- Handled deviation according to Novonordisk Quality Management process
- Represented during Audit and Inspections for the Safety system
- Communicate and involve relevant stakeholders -alignment with LoB stakeholders, primarily System managers, NNQAs/LoB QAs, System Owners, Project Owners
- Participate in system operation and maintenance in IT System Management
- Demonstrate proactiveness and ownership
- Performed Disaster Recovery Testing for Argus Safety system
- Supported in Azure cloud migration project
- Served as Validation lead for the Axway server OS upgrade
- Well aware of the software lifecycle process
- Supported peers in their daily tasks, reducing workload burden and allowing for increased focus on higher-priority assignments.
- Served in project that used Agile methodologies
- Manage own time planning and timely deliverables
- Reduced instances of non-compliance through meticulous monitoring of internal controls and periodic audits.
- Conducted risk assessments and recommended appropriate mitigation measures for the PV Safety system.
- Enhanced the performance of the Argus Safety application by implementing series of changes.
Associate Customer Support Specialist
IQVIA
12.2016 - 06.2021
- Company Overview: Bristol-Myers Squibb is an American pharmaceutical company, headquartered in New York City
- Triaging of tickets and appropriately routing it to the relevant groups
- Provide first line assistance to end users of our Global Lifecycle Safety Platform ensuring accurate logging and tracking of requests
- Issues assigned needs to be looked at and resolved at the first instance
- Working on the issues and providing the necessary evidence to the technical team to further resolve the issue
- System administration and first level issue management
- Ensure compliance with customers’ Service Level Agreements with respect to incident and request completion
- Strong knowledge on Argus and Console (Involving the configuration of Codelists, Products, Studies, expedited reporting rules, system configuration, user accounts
- Troubleshoot errors associated with case reporting and E2B
- Close liaison with second level teams and external vendors to work through complex support issues
- Ensures adherence to relevant support SOPs and WIs that relate to the provision of end user support and can support audits as required
- Implement, maintain and continually seek to improve procedures and processes used by the team
- With guidance can assist in the management and coordination of system deployments
- Play a key role in the communication cascade to customers, business partners and stakeholders
- Coordinate with internal and external service providers in the area of incident, problem, and change management
- Participating in project calls and Incident review calls
- Working closely with the SME’s to better understand the issue
- Able to work in shifts to support the team
- Ability to establish effective working relationships with all customers, partners and co-workers
- Perform other duties as directed
- Coordinate with internal and external service providers in the area of incident, problem, and change management
- Good understanding on E2B transmission of reports
- Hands on experience on performing MedDRA dictionary recode and loading
- Bristol-Myers Squibb is an American pharmaceutical company, headquartered in New York City
Unit Test Engineer, Documenting of RS, CS & DS
Accenture
Bengaluru
02.201 - 12.201
- Company Overview: Merck is an upgrade project and is the first Pharmaceutical company to upgrade from Argus 6.X to Argus 8.X
- Interacting with clients on updating RS, CS and DS documents
- Involved in writing Unit Test Cases for different Modules, test execution and reviewing test cases
- Documenting, implementing, monitoring and enforcing all processes and procedures for testing is established as per the standards defined by the organization
- Maintaining requirement traceability matrix to ensure the coverage
- Proactively highlight issues/problems in the project and participate in status/weekly meetings
- Verified Release Notes, Builds and other items before dispatch and involved in defect reporting
- Responsible for Bug tracking and closure and regression analysis throughout the SDLC
- Ensure the timely delivery of Test Cases of different testing milestones
- Client interaction, status meeting and technical calls with offshore and onsite team
- Responsible for Creating Generic & Project Specific Scripts
- Responsible for Review of Test Scripts
- Merck is an upgrade project and is the first Pharmaceutical company to upgrade from Argus 6.X to Argus 8.X
- Tools Used: HP-ALM, Toad
Test engineer
Accenture
07.2014 - 02.2015
- Company Overview: Ferring aims at validating the ARGUS applications and finding defects and logging them with appropriate explanations in the team site
- Worked in V&T Team (Validation & Testing)
- Worked in Requirement gathering and analysis, Design review, Case creation and maintenance based on CT (Clinical trial)
- Involved in writing Test Cases for different Modules, test execution and reviewing test cases
- Documenting, implementing, monitoring and enforcing all processes and procedures for testing is established as per the standards defined by the organization
- Responsible for Review of Test Scripts and quality-based productivity
- Ferring aims at validating the ARGUS applications and finding defects and logging them with appropriate explanations in the team site
Process Associate
First American India
Bengaluru
07.2012 - 09.2013
- Company Overview: First American Financial Corporation is a United States financial services company and is a leading provider of title insurance and settlement services to the real estate and mortgage industries
- Audit on-line applications for accuracy and completeness
- Entered data into designated database and forms
- Review and check applications and supporting documents
- First American Financial Corporation is a United States financial services company and is a leading provider of title insurance and settlement services to the real estate and mortgage industries
- Tools Used: FAST
Education
Bachelor of Computer Science -
Indian Academy Degree College
Skills
- Windows
- HP ALM
- SQL Developer
- SQL
- PL/SQL
- Regression testing
- Functionality testing
- Oracle Argus
- L1 Support
- Access Management
- L3 Support
- Configuration
- BA
Disclaimer
I hereby declare that the information furnished above is true to the best of my knowledge.
Training
- Manual Testing and SQL, Q Spiders, 02/14
- Manual and Automation Testing, Maintec Technologies Pvt. Ltd., 05/14
- Accenture Development Suite on Manual Testing, Accenture Services Pvt. Ltd., 06/14 - 07/14
Timeline
IT Validation and Compliance Specialist
Novonordisk
06.2021 - Current
Associate Customer Support Specialist
IQVIA
12.2016 - 06.2021
Test engineer
Accenture
07.2014 - 02.2015
Process Associate
First American India
07.2012 - 09.2013
Bachelor of Computer Science -
Indian Academy Degree College
Unit Test Engineer, Documenting of RS, CS & DS
Accenture
02.201 - 12.201
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