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Profile Details

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USD 20 /hr

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Hire Anupam M.

India

USD 20 /hr

Clinical research postgraduate with more than 11 years of experience in Medical Writing & regulatory submission

Profile Summary

Experience summary:
 Author and review regulatory periodic safety reports (Periodic Benefit-Risk Evaluation Reports Developmental
Safety Update Reports, Addendum to Clinical Overview, US Periodic Reports [Periodic Adverse Drug Experience
Report]), annual reports, safety summary reports, and signal assessment reports, Health Hazard Evaluations
(product quality complaints): collecting, organizing, analyzing, and presenting the data by means of company
templates, processes, and procedures.
 Author and review clinical trial safety narratives, clinical trial protocol disclosure and result summaries (FDAAA),
CTR summaries, abstract preparation, literature review (drugs and device) with the above-expected quality:
collecting, organizing, analyzing, and presenting the data by means of company templates, process and
procedures.
 Performed Clinical Study Report (CSR) data QC along with co-authoring of multiple sections of CSR, protocol,
updating IB under the guidance of the Clinical Lead.
Regulatory Submissions: Pre-regulatory submissions activities including Ethics Committee documents (like protocol,
IB, ICF, CRF, and other essential documents) submission, collection of site yearly documents, review of yearly site
reports along with the preparation of financial disclosure reports.
Clinical Operations: Clinical trial lab operation, managing operation of the SAE subcommittee at the clinical site.

Subject Matter Expertise

Services

Writing
Research

Writing Clinical Trial Documentation, Technical Writing

Research Systematic Literature Review, Secondary Data Collection

Work Experience

Senior Safety Document Reviewer

MMS Holdings Clinical Research Pvt. Ltd.

April 2020 - Present

PV Scientist: Aggregate reporting

IQVIA Technologies Pvt. Ltd.

October 2018 - March 2020

Medical Writer - Aggregate Reports

Sciformix Technologies Pvt. Ltd. A Covance Company

June 2016 - October 2018

Assistant Consultant - Medical Writing and regulatory submission services

ValueLabs LLP

November 2015 - May 2016

Senior associate: Medical Writing (Clinical Disclosure & Submission)

Tata Consultancy & Services

May 2011 - October 2015

Executive Assistant Pre-regulatory submission activities

Seth GS Medical College and KEM Hospital

August 2010 - February 2011

Education

Bachelors, Chemistry

Mumbai University

June 2005 - June 2008

Certifications

Advance Post-Graduate Diploma in Clinical Research and General Management

Clinical Research Education and Management Academy

July 2008 - August 2009