Hemanth Kumar Nyathani
Hyderabad
Overview
2
2
Certificates
15
15
years of professional experience
6
6
years of post-secondary education
Timeline
Safety Systems Configuration Manager
GSK
10.2023 - Current
Senior Principal Consultant / Principal Consultant / Sr. Consultant
Vitrana
08.2021 - 10.2023
Expert Systems Operations / Sr. Safety Processing Expert / Safety Processing Expert
Novartis
06.2013 - 08.2021
Drug Safety Associate
Synowledge LLC
09.2011 - 05.2013
HCPA
Mahindra Satyam BPO
06.2010 - 04.2011
Master of Pharmacy - Pharmacology
Kakatiya University
01.2008 - 01.2010
B.Pharmacy - Pharmacy
Kakatiya University
08.2002 - 05.2006
Summary
Innovative technology professional with several years of diverse experience. Skilled in enhancing systems and aligning technical solutions with business objectives. Proven success in leading projects from start to finish and contributing to organizational growth and success.
Skills
Proficient in managing Argus Safety and ARISg platforms
Proficient in E2B R3 regulatory standards
Implementation and testing of safety systems
Clinical study setup
Process efficiency improvement
Agile methodology expertise
Experience with CAPA management systems
Automated reporting using Power BI
Electronic Data Interchange (EDI)
Team Management & Stakeholder Communication
Work History
Safety Systems Configuration Manager
GSK
10.2023 - Current
- One of the key member for Argus 8.4.3 upgrade project
- Led global regulatory alignment projects (EU AxMP, IDMP, EDQM).
- Developed xcomments for ICSR reporting to local authorities.
- Managed vendor solutions to regulatory specs and led Argus configurations.
- Created Power BI dashboards for monitoring safety system effectiveness.
- Authored SOPs and trained teams on evolving regulatory frameworks.
Senior Principal Consultant / Principal Consultant / Sr. Consultant
Vitrana
08.2021 - 10.2023
- Led validation projects for E2B R3 profiles (EMA, China, Korea).
- Developed validation plans and executed scripts via HPALM.
- Delivered CAPA tools & reporting solutions integrated with Argus.
- Supported client interactions, agile workflows, and team delivery tracking.
Expert Systems Operations / Sr. Safety Processing Expert / Safety Processing Expert
Novartis
06.2013 - 08.2021
- Handled Argus console configurations and expedited rule validations.
- Conducted narrative writing, AE seriousness assessments, and causality reviews.
Drug Safety Associate
Synowledge LLC
09.2011 - 05.2013
- Conducted AE monitoring and ARISg case processing.
HCPA
Mahindra Satyam BPO
06.2010 - 04.2011
- Worked on drug safety study activities.
Education
Master of Pharmacy - Pharmacology
Kakatiya University
01.2008 - 01.2010
B.Pharmacy - Pharmacy
Kakatiya University
Warangal 08.2002 - 05.2006
Accomplishments
- Achieved Lab unit mapping project successfully by completing the analysis of EMA UCUM units with accuracy and efficiency.
Certification
LinkedIn Learning, Highlights: Project Management
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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