Hitesh Dubey
Mumbai,Maharashtra
Summary
To secure a challenging position where I can effectively contribute my skills as Software Professional, possessing competent Technical Skills.
I am a mature and confident person with experience, team leadership skills and the ability to create new sales and build on existing accounts. Committed manager with exceptional leadership, organisational skills and communication abilities leads high-performing cross-functional teams. Leads projects, company operations and business growth.
Overview
10
10
years of professional experience
6
6
years of post-secondary education
Work history
SENIOR PROCESS ANALYST
ACCENTURE
Bengaluru, India
05 2024 - Current
- Case review for proper and structured entry of data in serious and non serious adverse event cases into PV safety database (Argus) and extraction of follow-up information.
- Evaluation and assessment of case reports for seriousness, global listedness and causality of all serious and non serious adverse events as per standard documents.
- Verification of accuracy of MedDra and WHODD codings.
- Review and processing of different types of cases such as spontaneous, post marketing, clinical trials cases, etc.
- Review and processing of Litigation cases along with serious and Non serious assessment.
- Checking for quality reports for all the associates.
- Handling quality control meetings for associates and providing feedback to individual associates on the basis of their performance.
- Preparing and handling quality compliance and CAPA documents for the team for audits readiness.
TEAM LEAD
COGNIZANT
10.2021 - 06.2023
- Managers/Regional Affiliates through mail and Teleconference, so as to ensure accuracy and completeness of day to day task and resolving different issues as per requirement.
- Responsible for the career progression and development of associates and team.
- Working as a Team leader handling team and addressing team issues.
- Handling workflow influx and output efficiently as per SLA.
- Handling clients by providing them overview of team and workflow with presentations and on call discussions/mails.
- Coordinate and communicate effectively with primary contacts at client end to ensure smooth function and satisfactory progress of project work and timely resolutions of issues.
- Overall in charge of Day to Day activities in team.
- Audit handling and documents handling for audits. Data preparation related to audit and presentation of the same.
- RCA and CAPA preparation and action plans for missed case.
TEAM LEAD
TCS
12.2018 - 09.2021
- Managers/Regional Affiliates through mail and Teleconference, so as to ensure accuracy and completeness of day to day task and resolving different issues as per requirement.
- Responsible for the career progression and development of associates and team.
- Working as a Team leader handling team and addressing team issues.
- Handling workflow influx and output efficiently as per SLA.
- Handling clients by providing them overview of team and workflow with presentations and on call discussions/mails.
- Coordinate and communicate effectively with primary contacts at client end to ensure smooth function and satisfactory progress of project work and timely resolutions of issues.
- Overall in charge of Day to Day activities in team.
- Audit handling and documents handling for audits. Data preparation related to audit and presentation of the same.
- RCA and CAPA preparation and action plans for missed case.
QUALITY REVIEWER ICSR
TCS
05.2017 - 12.2018
- Case review for proper and structured entry of data in serious and non serious adverse event cases into PV safety database (Argus) and extraction of follow-up information.
- Evaluation and assessment of case reports for seriousness, global listedness and causality of all serious and non serious adverse events as per standard documents.
- Verification of accuracy of MedDra and WHODD codings.
- Review and processing of different types of cases such as spontaneous, post marketing, clinical trials cases, etc.
- Review and processing of Litigation cases along with serious and Non serious assessment.
- Checking for quality reports for all the associates.
- Handling quality control meetings for associates and providing feedback to individual associates on the basis of their performance.
- Preparing and handling quality compliance and CAPA documents for the team for audits readiness.
CASE PROCESSOR
TCS
12.2015 - 05.2017
- Perform drug safety data management processes combinations of case intake, triage, case entry, data entry, medical coding, narrative writing, peer review, case follow up, report preparation and submission.
- Structured entry of serious and non serious Adverse events into PV safety database and extraction of incremental information's from follow up reports.
Education
BACHELOR - Pharmacy
01.2012 - 01.2015
DIPLOMA - Pharmacy
01.2010 - 01.2012
HIGHER SECONDARY - Science
01.2009 - 01.2010
Skills
- Argus skills
- Pharmacovigilance skills
- QMS activity
- Quality analysis
- Capacity modelling
Languages
English
Hindi
Marathi
Personal Information
Title: Team Lead
Custom
- Green belt project, TCS, 2018-12-01, Green belt Project on scanned documents that can be converted into editable documents.
- Best Performer, TCS, 2019-08-01, Best Performer award for outstanding performance.
Custom
Green Belt project, Team lead, 6 months, 20, To convert scanned documents into editable documents.
Custom
To secure a challenging position where I can effectively contribute my skills as Software Professional, possessing competent Technical Skills.
Timeline
TEAM LEAD - COGNIZANT
10.2021 - 06.2023
TEAM LEAD - TCS
12.2018 - 09.2021
QUALITY REVIEWER ICSR - TCS
05.2017 - 12.2018
CASE PROCESSOR - TCS
12.2015 - 05.2017
DR. BHANUBEN NANAVATI COLLEGE OF PHARMACY - BACHELOR, Pharmacy
01.2012 - 01.2015
NSS COLLEGE OF PHARMACY - DIPLOMA, Pharmacy
01.2010 - 01.2012
MSBSHSE - HIGHER SECONDARY, Science
01.2009 - 01.2010
SENIOR PROCESS ANALYST - ACCENTURE
05 2024 - Current