プロフィール詳細

プロジェクトを作成

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Anupam M.に依頼

India

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

プロフィール概要

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.

専門分野

• ★ Pharmacovigilance/Drug Safety Monitoring
• ★ Medical Writing
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing

サービス

• Writing
• Research

Writing Clinical Trial Documentation, Technical Writing

Research Systematic Literature Review, Secondary Data Collection

職務経験

Senior Safety Document Reviewer

MMS Holdings Clinical Research Pvt. Ltd.

4月 2020 - 現在

PV Scientist: Aggregate reporting

IQVIA Technologies Pvt. Ltd.

10月 2018 - 3月 2020

Medical Writer - Aggregate Reports

Sciformix Technologies Pvt. Ltd. A Covance Company

6月 2016 - 10月 2018

Assistant Consultant - Medical Writing and regulatory submission services

ValueLabs LLP

11月 2015 - 5月 2016

Senior associate: Medical Writing (Clinical Disclosure & Submission)

Tata Consultancy & Services

5月 2011 - 10月 2015

Executive Assistant Pre-regulatory submission activities

Seth GS Medical College and KEM Hospital

8月 2010 - 2月 2011

学歴

Bachelors, Chemistry

Mumbai University

6月 2005 - 6月 2008

認定資格

• Advance Post-Graduate Diploma in Clinical Research and General Management

  Clinical Research Education and Management Academy

  7月 2008 - 8月 2009