I am a pharmacovigilance associate. Seeking a responsible and challenging position in a dynamic and stable workplace where I can enhance my professional skills and participate actively in the growth and development of the organization.
Overview
7
7
years of professional experience
Work History
Senior Drug Safety Associate
Qinecsa Solutions India Pvt Ltd
Mysore
05.2020 - Current
Role – Sr. Drug Safety Associate – Pharmacovigilance (vaccine and other pharma cases).
Perform one touch data entry and quality review of all type of serious and non-serious cases in accordance with global pharmacovigilance conventions and project specific standard work instructions within client, partner and regulatory timelines while meeting productivity and quality SLAs.
Consistent coding of diseases, adverse events, and medication according to the project specific coding conventions with the help of MedDRA and WHO Drug dictionary.
Writing concise, accurate and well-written case narratives.
Participated in training sessions with other team members on drug safety topics.
Expertise in vaccines, EVWEB, spontaneous, PMS, reports from study, ICSRs and partner cases.
Junior Data Analyst
Cognizant Technology Solutions
Navi Mumbai
08.2017 - 05.2020
Role – Junior Data Analyst – Pharmacovigilance (Independent Quality Check (IQC) of cases).
Performing KPI and quality assessment to be shared with client and also performing Independent Quality Check (IQC) of serious and non-serious cases on a daily basis and sending feedback to associates.
Conducting quality sessions on different scenarios, as per recent error trends to improve overall quality of case processing.
Client interaction (Telephonic and Video).
Education
Bachelor of Pharmacy -
Pune University
06-2017
Skills
Hands on experience on Argus and Arisg
Good knowledge of Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft access, Microsoft One Note, Microsoft Outlook
Maintaining good interpersonal relationships
Willing to work in any situation
Ability to work in a team efficiently
Domain skillset
Pharmacovigilance
ARGUS database
ARISg database
All type of case processing and quality review (Clinical trial, Literature, Litigation, Spontaneous, E2B, License Partner, vaccines)
MedDRA version 27.1
WhoDD
Special medical coding scenario
Narrative writing
SUSAR case processing
Well acquainted with fatal/life threatening case processing
Late case analysis
Communication module
Duplicate case check with QBE
Speciality in processing fatal and life threatening cases