Pooja Thakur
Pharmacovigilance, Data Management And Project Management
Sacramento,California
Summary
Insightful leader with experience directing and improving operations Proficient in best practices, GCP and regulatory requirements of clinical research industry operations. Diligent trainer and mentor with exceptional management abilities and results driven approach. Creative problem solver and highly committed with hardworking mentality to maintain quality of services.
Overview
11
11
years of professional experience
5
5
years of post-secondary education
Work History
Manager
ICON 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 the execution of all projects
- Manage, assign, coordinate, advise, and review the work of Project Team Members
- Identify project risks and issues, including the identification of options for resolution and recommended course of action
Assistant Manager
Covance
Bangalore
03.2018 - 11.2018
- Managed operations for Kit inventory center and for one of the complex team of 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 the team.
- Actively engaged in training, recruitment, people and project management.
- Frequent communication with global counterparts including study leads, project managers, data managers, global heads etc.
- Worked upon metric streamlining project using six sigma methodology and Lean Sigma.
- Monitor, track, manage and ensure resolution of all customer complaints, issues and concerns.
Team Leader
Cognizant Technology Solutions
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 the transition of entire Europe project from sponsor 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 the necessary guidance/reference documents pertaining to project.
- Ensure appropriate distribution of work and tracking of cases daily for the project. Reporting to the Team Manager / Operations Manager on performance, status and any escalations. Perform Billing and TAT calculation activity.
- Nomination of the team for any skill level trainings, monthly and quarterly awards. Timely Metrics capture and update quality tools and trackers of operational deliverables
- Independently managed various special projects involving manual submission to Health Authorities.
Associate Operations Specialist, Operations Specialist, Senior, Operations specialist, and Certified Client trainer
IQVIA
Bangalore
11.2009 - 04.2015
- 5.5 years of experience in Pharmacovigilance
- Processing of Safety data (spontaneous, trial and literature) an line listings according to applicable regulations
- Prepared training materials such as curriculum and instructional documentation to impart training to new hires and experienced staff. Participate in team meetings and provide 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.
Associate Manager
Covance
Bangalore
04.2001 - 08.2001
- Effective and timely adherence to management communications, meetings and procedures.
- Oversaw training and onboarding process for all newly hired employees within Data Management team.
- Instill a culture of continuous improvement, quality, productivity and profitability within the team. Helping team members to develop the skills they require to achieve the career goals. Being accountable for the activities and outcomes of the team, communicating issues to the management and taking corrective action where necessary
Education
Master of Science - Science and Commerce
Ramaiah College of Science
08.2007 - 09.2009
Bachelor of Science - Biochemistry, Biotechnology, Genetics
Bangalore University
08.2004 - 06.2007
Skills
Pharmacovigilance
undefinedTimeline
Manager
ICON Bangalore
09.2021 - 03.2022
Assistant Manager
Covance
03.2018 - 11.2018
Team Leader
Cognizant Technology Solutions
04.2015 - 11.2018
Associate Operations Specialist, Operations Specialist, Senior, Operations specialist, and Certified Client trainer
IQVIA
11.2009 - 04.2015
Master of Science - Science and Commerce
Ramaiah College of Science
08.2007 - 09.2009
Bachelor of Science - Biochemistry, Biotechnology, Genetics
Bangalore University
08.2004 - 06.2007
Associate Manager
Covance
04.2001 - 08.2001
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