Kanthi Kumar Narne

About Kanthi Kumar Narne

A dynamic and result driven professional with Total 4.5 years of indust 6 years of…

Experience

1. Pharmacovigilance Compliance

   Mylan

   Jan 2016 — Present · Hyderabad, IN

   Assist in the collection, dissemination and implementation of Regulatory Intelligence within Pharmacovigilance and related functions.Coordinating activities across three key areas comprising; the PV Quality Management System, PV System Compliance & CAPA and Safety Data Exchange Agreements (SDEAs). Including; Managing the PV Quality Management System• Generation and review of SOPs and Work Practice Documents (WPD) as and when applicable and assigned.• Assistance for ensuring compliance with the regulatory requirements and company SOPs. Being aware of PV regulations of the developed markets like US, EU is also expected.• Assisting the team in the notification, preparation, conduct of CAPA following Regulatory Authority inspections and internal and external audits (on-site and remote).• Assisting to ensure quality assurance (QA) of individual and aggregate safety reports are completed in a timely manner.• Assisting in the preparation and maintenance of Pharmacovigilance Agreements (PVA) with Business Partners and Service Providers.Ensuring the CAPA tracker is maintained.• Assisting the timely reconciliation of safety information with Affiliates, Business Partners and Service Providers• Build and maintain good relationships across functional units and company affiliates.

Skills

• Data Management
• Ich-Gcp
• Patient Recruitment
• Sas Programming
• Crf Design
• Pharmacovigilance
• Clinical Trials
• Ctms
• Clinical Development
• Clinical Data Management
• Regulatory Submissions
• Clinical Research
• Gcp
• Informed Consent
• Irb
• CRO
• Medical Writing
• Clinical Monitoring