Kranthi Kiran Kumar K

About Kranthi Kiran Kumar K

With over 17 years of experience in pharmacovigilance, clinical research, and global…

Experience

1. Pharma Lead Sme Delivery Lead Program Manager

   Birlasoft

   Mar 2024 — Present · Hyderabad, IN

   Oversee the ICSR management in LSMV and support the functional components of ICSR automation.• Medical review of ICSRs, including medical triage, coding, seriousness, expectedness, and causality assessment on behalf of the Sponsor.• Responsible for performance, compliance, and quality of the deliverables of MICC, ICSRs, PSURs, PBRERs, PADERs, ACOs, and Signal Management reports along with RMP.• Provide medical interpretations on AESIs and AOSEs.• Train the medical reviewers to ensure appropriate medical assessment of ICSRs, aggregate reports, and Signal activities.• Liaise between clients and internal stakeholders to provide pharmacovigilance (PV) and clinical support for applications and tools.• Conduct quarterly strategic meetings and also safety review meetings as required.• Oversee the automation of the intake and literature by supplying the necessary functional expertise and carrying out the tasks to guarantee the tool\'s functionality.• Lead solution requirements and architecture discussions, addressing organizational challenges with business and technical partners.• As a subject matter expert (SME), provide up-to-date information on the health authority regulations and requirements.• Responsible for managing PV projects, programs, and portfolios.• Respond to RFPs, providing strategic solution architecture and aligning with client needs.• Perform and prepare for internal and vendor audits along with the inspections (HA).• Primarily responsible for communicating with internal and client stakeholders, offering pharmacovigilance knowledge, and offering functional support for the tools and applications.• Responsible for overall solution requirements & architecture discussion, understanding the organization\'s obstacles with business and technical partners to ensure solutions and provide due diligence.• Collaborate with cross-functional teams to ensure the client\'s expectations are fulfilled as requested.

Education

• Sri Chaitanya College of Education

  Higher Secondary

  1998 — 2000

• Don Bosco High School - India

  SSC

  1986 — 1998

• Cranfield University

  Masters in Clinical Research

  2008 — 2009

• Jawaharlal Nehru Technological University

  Bachelor of Pharmacy - BPharm

  2000 — 2005

• Institute of Clinical Research India

  Post-Graduate Diploma

  2007 — 2008

Skills

• 21 Cfr Part 11
• Gcp
• Regulatory Affairs
• Pharmacovigilance
• Quality Assurance
• Quality Reviews
• Ich-Gcp
• Quality Assurance Review
• Pharmaceutical Industry
• Sop
• Process Automation
• Project Management
• Clinical Research
• Edc
• Team Management
• Regulatory Submissions
• Clinical Trials
• Team Mentoring