Naresh Oinam

About Naresh Oinam

Experienced professional with 11 years of working in the pharmaceutical industries.

Experience

1. Pharmacovigilance Project Lead

   ICON plc

   Aug 2024 — Present · Bengaluru, IN

   Resource management/Project set up/database configuration request/ migration/contract review/SMP generation/project specific plans/cross functional calls internal & external/sending units for invoicing/forecasting/revenue & gross margin/ finance and budget management/monthly project reports/KPI/reconciliation plans/audits and inspections/ CAPA review/close out activities-Is the Single Point of Contact (SPOC) for the contracted Pharmacovigilance activities-Act as a functional lead for full service studies and as a Project manager for Standalone studies-Responsible to support Pharmacovigilance Project set-up-Oversee the development of project specific plans (i.e. Safety Management Plan), project management plan, ADI log, risk & issue log, training matrix, reconciliation plans etc-Ensure accurate projections of units/hours (revenue and resources) finance, actual units/hours, revenue and gross margin for all Pharmacovigilance services. • Primary liaison for client and project team for Pharmacovigilance services/activities (time, scope, cost, quality, resource) matters with oversight from the Global Project Manager. Responsible to provide Pharmacovigilance Service input into the Project Management Plan throughout the lifecycle of the project. When assigned to a portfolio, ensures consistency of the PMP and safety documentation across all projects-Conducts safety presentations for bid defense, start-up meetings, kick off meetings, Investigator Meetings and other meetings as needed.• Provide guidance for any audit/inspection activities.• Monitor quality and compliance for safety deliverables and provides KPI for inclusion in monthly project reports.• Train/mentor newly hired Pharmacovigilance staff, on project specific task as requested.• Perform other activities as identified and requested by Pharmacovigilance management.

Education

• Ms Ramaiah College Of Arts Science and Commerce

  Bachelor of Science (B.Sc.)

  2007 — 2010

• DITMS

  Master of Business Administration - MBA

  2016 — 2018

• ICRI India

  PG. Diploma (Full time)

  2011 — 2013

Skills

• Communication
• Sas Programming
• Public Speaking
• Research
• Microsoft Office
• Management
• Tmf
• Clinical Trial Management System (Ctms)
• Sql
• Microsoft Excel
• Powerpoint
• V Lookups
• Leadership
• Microsoft Word
• Project Management
• Customer Service
• Powe
• Sas Base