Summary
Overview
Work History
Education
Skills
Timeline
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Pooja Thakur

Pooja Thakur

Sacramento,California

Summary

Insightful PV leader with experience starting up, directing and improving operations through effective employee motivational strategies and strong policy enforcement. Proficient in best practices, starting up new studies, GCP and regulatory requirements of clinical research industry operations. Diligent manager, trainer and mentor with exceptional management abilities and results-driven approach. Creative problem solver and highly committed to maintaining the quality of services and products.

Overview

15
15
years of professional experience

Work History

Safety & PV Project Delivery Lead

Syneos Health
12.2022 - 06.2024
  • Collaborated with Sponsor/Customer and major functional area leads (e.g. Project Management, Clinical Monitoring, SSU, Medical Writing, Data Management etc.) as the key liaison between the client and Syneos Health SPVG.
  • Ensured all project deliverables meet the internal and external customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.
  • Developed and maintained relationships with customers in alignment with their assigned projects. Ensured that individual project targets and client needs are met, services are provided with the highest quality standards, policies and procedures are followed.
  • Provided oversight of all project SPVG deliverables which encompasses all activities throughout the duration of the project/program.

Manager

ICON Bangalore
Bangalore
09.2021 - 03.2022
  • Maximized performance by monitoring daily activities and mentoring team members of project management administrative team
  • Expanded cross-functional organizational capacity by collaborating across departments on priorities, functions and common goals
  • Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground
  • Application of rigorous project management approach to ensure efficiency and effectiveness in execution of all projects
  • Manage, assign, coordinate, advise, and review work of team members
  • Identify project risks and issues, including identification of options for resolution and recommended course of action.

Associate Manager

Covance, Bangalore
Bangalore
11.2018 - 08.2021
  • Managed operations for KIC and Data management setup in India
  • Planning and execution of clinical data file project varying from phase 1 to phase of clinical trials
  • Involved in internal and external audits and major initiatives of team
  • Actively engaged in training, hiring and people management
  • Collaboration with global counterparts, study leads, project managers, data managers, global heads etc
  • Worked upon metric streamlining project using six sigma methodology and Lean strategy
  • Monitor, track, manage and ensure resolution of all customer complaints, issues and concerns
  • Conducting quality investigation and implementation of CAPAs
  • Presenting overall performance to sponsors and communicating the outcome to team members
  • Effective and timely adherence to management communications, meetings and procedures.

Team Leader/Lead Coder

Mumbai
Mumbai
04.2015 - 11.2018
  • Mentored and guided team members to foster proper completion of assigned duties and built strong relationships with sponsors through positive attitude and attentive response
  • Established open and professional relationships with team members to achieve quick resolutions for various issues
  • Took over transition of entire Europe project from client including 11 countries
  • Scope of work included translation of non-English language source documents to English and book-in in Argus Affiliate database
  • Prepared and reviewed all necessary guidance/reference documents pertaining to project
  • Ensure appropriate distribution of work and tracking of cases daily for project
  • Reporting to Team Manager / Operations Manager on performance, status and any escalations
  • Perform Billing and TAT calculation activity
  • Nomination of team for any skill level trainings, monthly and quarterly awards
  • Timely Metrics capture and update quality tools and trackers of deliverables
  • Independently managed various special projects involving manual submission to Health Authorities
  • Review of SOPs and WIs in accordance with project.

Operations Specialist

IQVIA, Bangalore
Bangalore
11.2009 - 04.2015
  • 5.5 years of experience in Pharmacovigilance
  • Processing of ICSRs according to applicable regulations
  • Prepared training materials such as curriculum and instructional documentation to impart training to new hires and existing staff
  • Participated in team meetings and provided regular feedback to operations team manager and safety management (LSM) on operational project metrics, out of scope work challenges/issues and successes
  • Reconciliation of adverse events and to provide oversight on operational activities.

Education

Master of Science - Microbiology

Bachelor of Science - Biochemistry, Biotechnology, Genetics

Skills

  • Pharmacovigilance
  • Data Management
  • Training and Development
  • People Management
  • Argus
  • Project Management
  • Coaching and Mentoring
  • Operations management
  • Verbal and written communication
  • GCP
  • Drug Safety
  • ICH
  • MedDRA
  • Audit
  • TMF
  • Veeva
  • Trifecta
  • Budget
  • Quality Investigation
  • CAPA
  • Staff Management
  • Key Performance Indicators
  • Improvement initiatives
  • Recruitment

Timeline

Safety & PV Project Delivery Lead

Syneos Health
12.2022 - 06.2024

Manager

ICON Bangalore
09.2021 - 03.2022

Associate Manager

Covance, Bangalore
11.2018 - 08.2021

Team Leader/Lead Coder

Mumbai
04.2015 - 11.2018

Operations Specialist

IQVIA, Bangalore
11.2009 - 04.2015

Master of Science - Microbiology

Bachelor of Science - Biochemistry, Biotechnology, Genetics

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