Hemanth Kumar Nyathani

A Certified Scrum Master (CSM) and people manager with 14 Years of experience in Pharmacovigilance/ Regulatory domain as a techno functional business analyst, project management, support of incident management, change request management, managing third party vendor ticket tools like (SNOW, Redmine, JIRA), validation lead responsible for complete product/ Software development life cycle (SDLC). As per Computer System Validation (CSV) guidelines – Documentation of Validation Plan, Project Plan, Functional Risk Assessment, GxP Assessments, URS/BRD, FRS, User guide, Operational & Performance Qualifications (OQ & PQ), Training Plans, Release Notes, VSR etc. Lead Safety System (Argus and ArisG) configuration - changes or upgrade as per business requirement or change request in compliance with regulatory changes EDQM, UCUM, E2B (R3 xml files in HL7 format) European Region (EMA), Medical Device Regulation (MDR), IDMP, United States FDA (FAERS), Germany (BfArM), Japan (PMDA), China (NMPCDR) profile, data migration projects. Scrum Master- Mentoring and coaching Scrum team by removing impediments using agile mindset and Scrum framework to ensure quality deliverables to business as per sprint. Skills: Project Manager- Project Plan, Project Schedule, and Resource planning, budget allocation, Project updates. Project closure, Release Notes, Client interaction. Preparation of product validation life cycle documents (Test plan, Validation plan, Configuration Management Plan (CMP), Configuration Base Document (CBD), Validation Summary Report (VSR), User guide, Functional Requirement specification (FRS) , Functional Design Document (FSD), Traceability Matrix (TM), System Test (ST), User Acceptance Test (UAT) scripts. Scrum Master- Sprint planning, Sprint backlog, Retrospective sprint review, Daily stand-up call, sprint refinement. Business Analyst- Business requirement specification (BRS) document authoring, participation in business requirement workshops to gather the requirements. Effective time management and organizational skills to meet the project deliverables. Critical thinker and ability to demonstrate logical approach to problem solving Strong negotiation and influencing skills particularly at senior levels of an organization Able to priorities work and balance competing demands Able to think strategically, creatively and to see the bigger picture Able to deal with conflict and mediate Able to deal with ambiguity and cope with change Able to inspire and motivate teams.

Certified ScrumMaster (Certificate ID: 001428241) from ScrumAlliance.

• Bronze Award in recognition of EMA, China R3 project.
• Multiple Applause Awards in recognition of successfully closure of Critical Regulatory Authority CAPA, defined Process Change in Clinical Study configuration and lead case correction projects with vendors.

GATE, 2007, 1849, 90.48

Spandana Gorantla

Microsoft Office Suite (MS Project and MS Visio), Agile, Scrum, SAFe, ArisG 6 or higher, ARGUS 7.0, 8.2, CdsDB (similar like RIMS), ICH, GPV module VI, US 21 CFR Part 11, GAMP5, Annex 11, HIPPA, GDPR, xEVMPD, IDMP, EDQM, MedDRA, GxP, NDA, ANDA, IND, Oracle DB 10g, 11g, 12c, SQL Server 2008, SQL developer and Toad for Argus safety., SAP Business Objects BI (Quadrant, LogiReport), Cognos., JIRA, Redmine, MS Project., ALVIS, HP-ALM, HP proton.

• Father's Name: N. Damodar
• Mother's Name: Prameela
• Nationality: Indian
• Marital Status: Married

I hereby declare that information furnished above is true to the best of my knowledge.

• GSK Silver Award: Received for LAb unit mapping project between Veeva Clinical system and Argus Safety system using Flexible code list.