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Abhilasha - Gaurav CV - Edited

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60 views3 pages

Abhilasha - Gaurav CV - Edited

Uploaded by

shaan shanawaz
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Abhilasha Gaurav

Clinical Research Scientist (Team Member -


Clinical Strategy-Branded Market (Clinical
scientist)

7 +Years (+91) abhilashagaurav42


9431541667 @gmail.com

Profile Summary

Overall I have about 7+ years of experience in pharma and


academics.
Key skills

Clinical Trials
Education
Clinical Data Management
Publishing
M. Pharma, 2017
Pharma Marketing
Banasthali Vidyapith
Market Research

Pharmacovigilance B. Pharma, 2011

Strategy Consulting Banasthali Vidyapith

Project Management
12th, 2010
Medico Marketing
CBSE, English
Case Processing

Medical Writing 10th, 2008

Clinical Research CBSE, English

Technical Writing

Pharmacovigilance (QA) Work Experience


Scientific Writing

Dec 2022 - Present

Clinical Research Scientist (Team Member - Clinical Strategy-


Personal Information
Branded Market (Clinical scientist)
Dr Reddy’s laboratory
City Hyderabad
The primary role is more scientific with a focus on searching
Country INDIA
the literature, understanding the pathophysiology of the
disease, identifying the gaps in the existing therapy, proposing
a new concept or evaluating the latest concepts, searching
for proof-of-concept animal models, etc.
Languages
Reviewing and Providing inputs to clinical-regulatory strategies

English

Hindi
Professional links For differentiated formulations, complex generics for multiple
therapeutic areas.

Liaison with CFT to obtain critical strategy inputs.


https://www.linkedin.com/in/abhilasha-
gaurav-866a4887 Maintaining the trackers for the timelines and list of clinical
regulatory strategies

Supporting in reviewing in licensing or out-licensing programs,


providing required literature and inputs, etc.

Knowledge of MS PowerPoint is desired to prepare day-to-day


presentations.

Mar 2021 - Dec 2022

Drug Safety Associate


Qniecsa Solutions Formally known as Bioclinica

As a case processor in an Argus database with knowledge


about Medra browsers, codes, and Quality Assurance.

As Case Processor/Case Reviewer:

Confirms case validity

Responsible for data entry of Individual case safety reports into


the safety database.

Review and evaluate AE case information to determine required


action based on and following internal policies and procedures.

Process all incoming cases to meet timelines.

Full data entry including medical coding and safety narrative


as required.

Enter and code, as applicable, case data, including but not


limited to event, seriousness, reported causality (when
appropriate), medical history, and laboratory data as provided
by the reporter.

Code products specified as suspect or concomitant by the


reporter

Provide the narrative, as required

Review Adverse Event (AE) report data for completeness and


verify certain fields to determine as critical (including but not
limited to reportability) as well as conformity to E2B standards.

Initiate follow-up activities to obtain additional information and


clarification, as appropriate.

Forward cases for case review or invalid workflow in the global


safety database.

Peer review the cases and evaluate for accuracy,


consistency, and completeness in the safety database
against the source document. This includes but is not limited
to, checking the consistency of narrative and other data
fields, and ensuring the main reason for any delay is entered
in the routing comment as appropriate.

Confirms event term selection and coding

Confirms/assesses event seriousness

Performs listed ness assessment


Initiate the SUSAR process via notification to Pfizer and
routing of the case back to Pfizer for processing.

Determine whether additional queries through the DSU are


needed at this stage and document them in the global safety
database with a brief description of the information needed.

Identify spontaneous cases that are a result of stimulated


reporting by adding the appropriate case classification.

Correct the data entry errors, if any, before routing the case to
the global safety database.

Track and document all observations and recommendations on


the defect tracker

Ensure adherence to the Quality Assurance Program and


conduct the Quality Control (QC) review as outlined.

As Medical Coder:

Responsible for coding all medical history, events, drugs


/procedures/indications and laboratory tests according to the
appropriate dictionary (E.g., MedDRA, Company Product
Dictionary, WHO-DD).

Dec 2018 - Mar 2021

Medical Writer
Medip Academy

Scientific and international publication, Publication house,


research publication, medical writing.

Technical writer, format articles for journals from authors'


manuscripts and ensure that proper template is applied. Format
tables and figures to the specifications of journals. Key copy
editing and proofreading changes in text tables. Figures
accurately through multiple production stages in Microsoft.

Jul 2017 - Nov 2018

Assistant Professor
Samskruti College of Pharmacy affiliated with JNTHU Hyderabad

To teach dedicated and experiential settings of pharmacy


practice to students. Develop clinical practice settings
supporting experiential teaching activities and promote
scholarship. Teach and facilitate a distance-learning
environment in pharmacy practice.

Projects

365 Days
EXTENDED BETA-LACTAMS ENZYMES (ESBL)

It is an antibiotics study on water samples from different dirty


water sites.

The project was completed b y CSIR- IITR Lucknow, Uttar


Pradesh.

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