プロフィール詳細

プロジェクトを作成

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Dr. Alpa B.に依頼

India

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

プロフィール概要

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.

専門分野

• ★ Medical Devices
• ★ European Medical Device Regulation (MDR)
• ★ Research
• ★ Clinical Evaluation Reports (CER)
• ★ Medical Writing
• ☆ Medical Device Regulatory Consulting
• ☆ Medical Terminology
• ☆ Medical Sciences
• ☆ Peer Review
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing

サービス

• Writing
• Research
• Consulting

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, Systematic Literature Review

Consulting Regulatory Consulting

職務経験

Technical Writer

Tata Consultancy Services Ltd

7月 2021 - 現在

Senior Medical Writer

HCL Technologies Ltd.

3月 2019 - 6月 2021

Senior Safety Associate

Indegene Lifesystems Private Limited

2月 2016 - 3月 2019

学歴

Bachelor of Dental Surgery

K.L.E's Institute of Dental Sciences

10月 2003 - 8月 2009

認定資格

• Post Graduate Diploma in Clinical Research and Pharmacovigilance

  GITS Academy

  1月 2021 - 現在