KAUSHAL TRIPATHI
Pharmacovigilance Associate
Delhi NCR
Summary
I am a Pharmacovigilance Associate and immediate joiner with 2.4 years of experience in identifying, assessing and preventing adverse effects or medications, vaccines, medical devices and related pharmaceutical items. Dedicated expert with focus on maintaining drug safety by preparing and reviewing data and reports. Meticulous when authoring professional documents and reviewing scientific literature.
Overview
7
7
years of professional experience
7
7
years of post-secondary education
2
2
Certifications
Work History
Pharmacovigilance Scientist
Tata Consultancy Services
Pune
01.2023 - 10.2023
- Analytical and good knowledge in Pharmacovigilance domain experience, collaborating as a strong team player to uncover and address pharmaceutical safety issues
- Worked with case processing team in pharmacovigilance, good knowledge about case processing activity, the cases processed in Sapphire, Argus, ARIS-G (Databases)
Safety Associate Trainee
IQVIA RDS
Bangalore
02.2021 - 11.2022
Handled a vaccine and medical device projects, worked as a Pharmacovigilance case processor of Spontaneous, Non interventional study,Licensing partner and medical device clinical trial cases, SENR review, Query handing in EDC,Dossier preparationand Narrative writing.
Research Trainee
Defence Research Development Organization(DRDO)
Delhi
07.2016 - 08.2017
- Assisted scientists by collecting and organizing laboratory data.
- Prepared reagents and solutions following standard laboratory formulas and procedures.
- Assisted with preparing project-related reports, presentations and manuscripts.
- Completed research, compiled data, updated spreadsheets, and produced timely reports.
Education
Diploma In Pharmacy -
Roorkee College of Pharmacy
Uttarakhand 08.2010 - 08.2012
Bachelor Of Pharmacy - Pharmaceutical Sciences
Hemwati Nandan Bahuguna Garhwal University
Uttarakhand 09.2012 - 08.2015
M.pharmcy - Medicinal And Pharmaceutical Chemistry
Kumaun University Nainital
Uttarakhand 08.2015 - 02.2018
Skills
Performed data entry, coding relevant medical terminology, writing descript narratives
Performed quality review and evaluation of cases with an emphasis on key performance indicator
Assisted with reconciliation, driving and ensuring case closure within stipulated timelinesReceipt and confirmation of receipt of information regarding serious and non-serious AE from clinical trial, solicited and spontaneous source
Duplicate check in the database and triaging of cases, Assessment of seriousness and labeling of the events
Coding of suspect drugs, concomitant drugs, treatment drugs and past drugs using appropriate company drug dictionary and WHO drug dictionary
Responsible for clinical trial case processing and follow up information in ARGUS and ARIS-G safety database
Review of SENR,Source Document review and expedited report processing
Dossier preparation, Query creation (Through EDC) and follow-upCreating ICSRs into IRT
Handling invalid/ duplicate items in IRT and ARIS appropriately through reference to SOPs Relevant training and the ARIS user manual
Acknowledging receipt of ICSRHandling and processing ICSRs (performing accurate data capture and clinical assessment) in ARISGenerating and forwarding appropriate queriesTypes of cases handled: Clinical Trial, Non-Interventional Study, Spontaneous, Non-Interventional program and MAP
Excellent Communication
Written Communication
Organization and Time Management
Flexible and Adaptable
Accomplishments
Awarded by IJRULA as best researcher award in 2018.
Certification
NSS B
Timeline
Pharmacovigilance Scientist
Tata Consultancy Services
01.2023 - 10.2023
Safety Associate Trainee
IQVIA RDS
02.2021 - 11.2022
Novel wound healing project in DRDO,Delhi
08-2017
Research Trainee
Defence Research Development Organization(DRDO)
07.2016 - 08.2017
M.pharmcy - Medicinal And Pharmaceutical Chemistry
Kumaun University Nainital
08.2015 - 02.2018
Bachelor Of Pharmacy - Pharmaceutical Sciences
Hemwati Nandan Bahuguna Garhwal University
09.2012 - 08.2015
NSS B
01-2011
Diploma In Pharmacy -
Roorkee College of Pharmacy
08.2010 - 08.2012