Shailpik Bhattacharjee

Drug Safety Associate @ Qinecsa Solutions

About

I have done a bachelor of pharmacy(b.pharma) under graduate degree in 2015 from west bengal university of technology currently known as maulana abul kalam azad university from located in kolkata,west bengal,india and registered pharmacist under pci(registration no: A16587).I have worked in several companies including cipla pvt. ltd. located in kumrek,sikkim,india as a quality control officer after then i joined as a medical coding associate in dcg data core india pvt. ltd. located in saltlake city,kolkata,west bengal,india and my present company is clario(best of ert and bioclinica bioclinica india pvt. ltd. mysuru,karnataka,india as a drug safety associate,drug safety services.I have also done an advanced postgraduate diploma program in clinical research & managment from clini india,campus: clini research services bangalore,karnataka in 2017 with registration no: CI-BANG-331.

Country

India

City

Kolkata

Industry

Pharmaceuticals

Skill

Pharmaceutical Sciences, PV, Regulatory Submissions, Electronic Data Capture (EDC), Adverse Events, Office 365, Standard Operating Procedure (SOP), GVP, Medical Devices, Safety Case, Clinical Research Experience, English, Patient Safety, Quality Patient Care, Patient Care, Patient Support, Patient Assessment, Patient Outcomes, Patient Registration, Patient Monitoring

Experience

Drug Safety Associate

Qinecsa Solutions

2022-5 - 2022-11 · 7 mos

Mysore, Karnataka, India

I worked in this company as a drug safety associate and was responsible reviewing, interacting, data Entering, primary and Peer Reviewing, routing and distributing of reports like ICSR, SUSAR, PSUR, DSUR, Non-interventional study, literature report and invalid cases for client Pfizer's assistance as a vendor on argus safety database. In argus database from general tab to additional information tab I was responsible for reviewing each tab of each patient reports carefully and entering data from the attached documents of the report, I was also responsible for distributing the case to RA whenever needed, coding product from CDD or WHO-DD, coding adverse events from Med-DRA and also responsible for determining the causality of adverse event and detecting signals from incoming cases, Also I was responsible for taking follow-ups of previously cases which was routed to distributions. In meetings I was responsible for addressing client’s queries and if any escalations occur justifying with proper RCA and CAPA.

Drug Safety Associate

Qinecsa Solutions

2021-1 - 2022-11 · 1 yr 11 mos

Mysore

Drug Safety Associate

Bioclinica

2021-1 - 2022-5 · 1 yr 5 mos

Mysore, Karnataka, India

Reporting and reviewing of ICSRs,SUSARs,PSURs,literature study reports,non- interventional study reports,spontaneouss,product quality and device related reports,case study in different workflows in argus safety database. Determination of case validity by reviewing both initial and follow-ups reports,pharmacovigilance monitoring, working different products in microsoft office 365. Also responsible for generating and submitting patient safety reports to regulatory authority with maintaining timelines.

Medical Coder

Data-Core Systems Inc.

2019-4 - 2019-7 · 4 mos

Kolkata Area, India

Medical Coding by analysing medical reports received from ED Departments of hospitals.

Quality Control

Cipla

2017-2 - 2017-3 · 2 mos

Sikkim

Quality Control testing via HPLC,Dissolution,Disintegration,TLC,Fibrilator,Measuring,Determining,Calculating and Giving approval of API came from Manufacturing Departments of Tablets,Syrups,FPS,Nasals,Capsules.