Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Sandeep Singh

Team Lead (Drug Safety)
Bengaluru,KA

Summary

I am credited with 6 years of experience in Pharmacovigilance and worked on Sceptre, Arisg and Argus safety databases. I have performed various role during this tenure starting from Drug safety associate and promoted to Quality reviewer and Trainer. I am currently spearheading with TCS as Team Lead.

Overview

6
6
years of professional experience
8
8
years of post-secondary education
2
2
Certifications

Work History

Assistant Team Lead

TCS
Bangalore
11.2020 - Current
  • Pharmacovigilance Roles & Responsibilities.
  • Quality Review of all kind of cases (Clinical trial, Spontaneous, Literature, litigation cases, Regulatory and Social media cases).
  • Follow-up with clients regarding outstanding queries and reconciliation of discrepancies.
  • Project management and people management.
  • Shared Daily and Weekly reports with the client.
  • Client communication regarding the workflow and project status.

Senior Drug Safety Associate

Navitas lifesciences
Bangalore
01.2020 - 08.2020
  • Pharmacovigilance Roles & Responsibilities.
  • Doing Quality Check for spontaneous, solicited, Literature cases in ARGUS version 7.0.7.
  • Assess expectedness of adverse events.
  • Code event as appropriate.
  • Responsible for identifying duplicate/invalid ICSRs in ARIS and handling as per relevant SOP.
  • Ensuring accurate collection, recording, review and reporting of literature searches conducted.
  • Review of literature articles to identify case safety reports.

Senior Drug Safety Associate

Bioclinica
12.2015 - 10.2019
  • Mysore Domain: Pharmacovigilance Roles & Responsibilities.
  • Responsible for data entry of case safety reports into the safety database.
  • Hands on all types of cases (spontaneous, study, pure clinical trial, literature cases).
  • Review and evaluate AE case information to determine validity of a case, seriousness and expedite as per client and internal policies and procedures.
  • Process all incoming cases in order to meet timelines.
  • Full data entry including medical coding and safety narrative.
  • Responsible for coding all medical history, events, drugs/procedures/indications and laboratory tests according to the appropriate dictionary (For e.g.
  • MedDRA, Company Product Dictionary, WHO-DD).
  • Responsible for coding to the exact term reported by the reporter and ensure that the term coded to exact SOC [system organ class].
  • Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in various fields.
  • Ensure that the narrative is written in chronological way to represent exactly what happened to the subject [patient] while on suspect drug.

Drug safety Asociate, IQVIA
Bangalore
10.2014 - 06.2015
  • Pharmacovigilance Roles & Responsibilities.
  • Triage of ICSRs to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities.
  • Coding of ICSRs in the safety database, writing case summaries, assessing causalities and writing company comment.
  • Managing duplicate cases appropriately.
  • Registration/initiation of ICSRs into the safety database.
  • Conducting duplicate searches prior to registration and identifying potential duplicates.
  • Data validation i.e.
  • Cross checking against source documentation.
  • Expertise in professional mentoring and training.

Education

M. Pharma -

Babu banarasi das University
01.2012 - 01.2014

B. Pharma - undefined

Unites institute of pharmacy
01.2007 - 01.2011

12th - Science

01.2006 - 01.2007

10th - undefined

01.2004 - 01.2005

10th - undefined

Skills

    Certification in basic to Advance Excel

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Certification

Certification in aggregate report (Covalent technologies) o PSUR/PBRER, PADER, Signal detection, RMP and ACO

Timeline

Assistant Team Lead

TCS
11.2020 - Current

Senior Drug Safety Associate

Navitas lifesciences
01.2020 - 08.2020

Senior Drug Safety Associate

Bioclinica
12.2015 - 10.2019

Drug safety Asociate, IQVIA
10.2014 - 06.2015

M. Pharma -

Babu banarasi das University
01.2012 - 01.2014

B. Pharma - undefined

Unites institute of pharmacy
01.2007 - 01.2011

12th - Science

01.2006 - 01.2007

10th - undefined

01.2004 - 01.2005

10th - undefined

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Sandeep SinghTeam Lead (Drug Safety)