Summary
Overview
Work History
Education
Skills
Certification
Internship
Timeline
Generic

Dr Prathitha Seshadri

Summary

Medical writer with 5 years of experience in creating and reviewing Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF) reports, and Summary of Safety and Clinical Performance (SSCP) for medical devices. Proficient in compliance with EU Medical Device Regulation (MDR) standards, ensuring high-quality documentation. Demonstrated ability in Clinical Evaluation Plan (CEP) development and Adverse Event (AE) extraction. Committed to delivering precise and regulatory-compliant medical writing solutions.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Medical writing consultant

MPK Private Ltd
08.2023 - Current
  • Contributed to the strategic diversification of a packaging consultancy firm into the medical writing space, driven by client demand for regulatory documentation support.
  • Spearheaded the development of EU MDR-compliant Clinical Evaluation Report (CER) templates for medical device clients, ensuring alignment with regulatory standards and industry expectations.
  • Acted as a liaison between packaging and medical device clients, leveraging cross-industry knowledge to bridge technical communication gaps and establish a new documentation service vertical.

Senior Medical Writer

L&T Technolgy services
07.2022 - 08.2023
  • Medical Writing and Document Management: Authored and reviewed clinical documents such as Investigation Brochure and CSR
  • Reviewed and processed safety events, managed adverse event follow-ups, and contributed to safety database accuracy. Played a key role in the development of safety management plans and supported post-marketing safety activities.
  • Provided editorial support and managed document review processes within the Patient Safety database.

Medical writer

HCL technologies
10.2019 - 06.2022
  • Led the systematic extraction and analysis of adverse events from clinical trial data to support drug safety assessments.
  • ·Performance Excellence: Awarded ‘Star Performer of the Quarter’ for excellence in AE extraction.
  • Prepared and reviewed clinical evaluation reports (CER), summary of safety and clinical performance (SSCP), and clinical evaluation plans (CEP) in compliance with regulatory guidelines.
  • Developed clinical study reports (CSR) and investigator brochures to document trial results and ensure accurate communication of safety and efficacy data.
  • Worked as a Project Lead for Adverse Events extraction, conducting systematic literature reviews and analyzing ADR/AEs based on severity and frequency.

Education

Master of Science - Pharm D

Sri Ramachandra Institute of Higher Learning
Chennai
10-2019

Skills

  • Regulatory writing
  • Clinical document development
  • Adverse event analysis
  • Medical writing standards
  • Clinical Evaluation Report (CER) - EU MDR
  • Clinical Evaluation Plan
  • Literature Review
  • Embase, Pubmed
  • Endnote
  • Clinical trails
  • Clinical Research
  • Clinical study Report &Investigator's Brochure

Certification

  • Basic Life Support (BLS) - CPR training
  • Executive Diploma in Nutritional Gynecology (ongoing)
  • Clinical Research course - NIDA
  • Clinical Evaluation for medical writers - Udemy

Internship

Hospital-based clinical research (June 2018 - May 2019)

  • Assisted in clinical evaluations – analyzing patient history, diagnosis, and evaluating the rationale of drug prescription, follow-up in various departments including oncology, pulmonology, pediatrics, dermatology, obstetrics and gynecology, neurology, emergency medicine, psychiatry, and general medicine, and also provided patient counseling for the outpatient patients
  • Thesis – As a part of curriculum in the Emergency department of SRIHER ,Topic: Pain management and its relevance to patient satisfaction in RTA patients in emergency department, Clinical Guide: Dr TV Ramakrishnan, HOD – Emergency. This project thesis is under the process of getting published in a medical journal with the help of Clinical Guide

Timeline

Medical writing consultant

MPK Private Ltd
08.2023 - Current

Senior Medical Writer

L&T Technolgy services
07.2022 - 08.2023

Medical writer

HCL technologies
10.2019 - 06.2022

Master of Science - Pharm D

Sri Ramachandra Institute of Higher Learning
Dr Prathitha Seshadri