The document contains the resume of Pooja Tiwari. She has over 5 years of experience in clinical research and pharmacovigilance. Currently she works as a Principal Technical Analyst at Aris Global Software Private Ltd in Bangalore. Previously she has worked as a Senior Pharmacovigilance Specialist at Quintiles Technologies India in Bangalore. She is seeking a position that allows her to utilize her knowledge and skills in pharmaceutical sciences and offers challenging responsibilities and opportunities for learning and growth.

1. Pooja Tiwari
#17 First floor 36th cross 9th A main 5th block Jayanagar,
Bangalore - 560011
Mobile: 9538705759; 9886202037
E-mail: poojapareek31@gmail.com
To work in a creative and challenging environment, that blends with my nature of solving difficult
tasks within stipulated timelines. To work in a place where I can constantly learn and contribute to
successfully deliver solutions and be a key team player and develop both as a team player and as an
individual. Seeking a position to utilize my knowledge, expertise & skills in the field of pharmaceutical
sciences in a constant learning environment offering challenging responsibilities along with
effectively striving to be an asset to the employer organization and aid their growth along with
personal and professional growth.
SYNOPSIS
 Result oriented, proactive and hard working professional with post graduate degree in Industrial
microbiology and 5.7 years of experience in Clinical research.
 Worked as Senior Pharmacovigilance specialist (Intake lead) in Quintiles Technologies India,
Bangalore for 5.3 years.
 Currently working in Aris Global Software Private Ltd, Bangalore (Global customer support) as
Principal technical analyst (SME) for ARIS G Safety product.
CORE COMPETENCIES
Clinical Research- Pharmacovigilance
• Review, assess and process safety data received from various sources and distribute
reports/data onwards to Client/ Regulatory Authorities.
• Lead additional tasks in the safety projects ensuring all activities are completed on time, within
budget and meeting quality standards.
• Build a positive, collaborative team environment with project team members; lead by example,
provide training and mentoring for project team members and department staff.

2. CAREER CONTOUR
Since 09th
March 2015- Principal technical analyst (SME) - Aris Global Software Private Ltd, Bangalore
Responsibilities-
• Currently working with testing team for the release of new version of products IRT, OST and
ARIS G.
Since April 01th
2014 – 02ND
March 2015- Senior operations specialist, Quintiles Technologies India
-Bangalore
Responsibilities
 Worked on ARGUS database.
 Acts as an SME and oversee, review and ensure that the available resources such as User
Manual and product/protocol guidelines are adequate to improve the quality of the reports and
thereby performance of the team.
 Identify coordinator, franchise, team and/or process related issues and escalate to appropriate
levels of management both locally and client side.
 Involved in intake, case processing and final review of Adverse Event data.
 Perform Quality checks of the entire case including narrative
 Ensure accurate coding of adverse events using the MedDRA Dictionary.
 Proactively identify issues and proposed solutions. Represent the department at client and other
internal meetings.
 Was engaged in the role of Intake lead.
01st
April 2011 to 31st
March 2014 – Operations Specialist, Quintiles Technologies India -Bangalore
Responsibilities
 Worked on Oracle AERS database.
 Receive, triage, performing medical entry and source document verification and process SAE
and /Adverse event reports from various sources on time and quality standards.
 Writing narratives: Create complete, accurate and concise narratives adhering to established
processes.
 Ensure accurate coding of adverse events using the MedDRA Dictionary.
 Ensuring reports are sent to client (submission in the client database) within agreed timelines;
updating narratives when updated information is received, as appropriate; liaising with client,
executing case closure, and reconciliation
 Identifying SAEs and AEs from literature sources and processing them appropriately.6.
Identifying suspect product following receipt of report; identifying reporting sources; and
assessing reportability and expectedness of events.
 Prioritize cases according to regulatory and project/client requirements.

3. 04th
November 2009 to 31st
March 2011 – Associate Operations Specialist, Quintiles Technologies India
Bangalore
Responsibilities
 Receive, triage, review and process SAE and /Adverse event reports from various sources on
time and quality standards.
 Writing narratives: Create complete, accurate and succinct narratives adhering to established
processes.
 Coding terms, as appropriate.
 Ensuring reports are sent to client (submission in the client database) within agreed timelines;
updating narratives when updated information is received, as appropriate; liaising with client,
executing case closure, and reconciliation.
 Identifying SAEs and AEs from literature sources and processing them appropriately.
 Identifying suspect product following receipt of report; identifying reporting sources; and
assessing reportability and expectedness of events.
ACADEMIA
Last Date Attended Institution Name,
Country
Education Level/Degree Area of Study
10/2009 Institute of Clinical
Research of India,
India
PG Diploma in Advanced
Clinical Research
Clinical Research
06/2007 School of Life
Sciences, India
MSc Industrial
Microbiology
05/2005 DR. Zakir Hussain
Acadamy, India
BSc Microbiology
PERSONAL DOSSIER
Date of Birth 30 Sep 1984
Marital Status Married
Gender Female
Languages Known English and Hindi.