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Profile Details

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USD 30 /hr

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Hire Dr. Alpa B.

India

USD 30 /hr

Medical writer with 8+ years of experience in writing CEPs, CERs, PMSRs and SSCP for Class II Medical Devices

Profile Summary

I am Dr. Alpa Ben, a BDS graduate from India. I have been working with healthcare service industry from past 8 years and have experience in various domains such as Regulatory Affairs, Pharmacovigilance, and Medical Affairs (Complaints Analysis and Labelling - CCDS/PI/PIL). I have good knowledge of MDR and MEDDEV 2.7/1 revision 4. I have reviewed and developed Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CERs), and Post-Market Surveillance Report (PMSR) and Summary of Safety and Clinical Performance for Class II Medical devices. I have also tasks such as comparisons between Company Core Date Sheet (CCDS) and local labels to identify discrepancies and assign rankings for the discrepancies as per the client requirements and processed end-to-end ICSRs (includes triage, duplicate search, data entry, processing complaints, causality assessment, narrative writing, dossier preparation, encoding verbatim terms using MedDRA) for Class II and III Medical devices.  I have: a) prepared training materials and trained new joiners, b) actively attended client calls and effectively communicated to the client if any discrepancies or challenges observed which was resolved following discussions on the same.

Subject Matter Expertise

Services

Writing
Research
Consulting

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, Systematic Literature Review

Consulting Regulatory Consulting

Work Experience

Technical Writer

Tata Consultancy Services Ltd

July 2021 - Present

Senior Medical Writer

HCL Technologies Ltd.

March 2019 - June 2021

Senior Safety Associate

Indegene Lifesystems Private Limited

February 2016 - March 2019

Education

Bachelor of Dental Surgery

K.L.E's Institute of Dental Sciences

October 2003 - August 2009

Certifications

Post Graduate Diploma in Clinical Research and Pharmacovigilance

GITS Academy

January 2021 - Present