Summary
Overview
Work History
Education
Skills
Disclaimer
PROFILE SUMMARY
Timeline
Generic

Sripathi Vattikuti

Technical Manager - Medical Writing
Hyderabad

Summary

Dedicated professional in medical writing, clinical research, and healthcare, focused on advancing the life sciences sector. Committed to leveraging expertise to support innovative projects and enhance organizational growth. Actively pursuing industry trends and best practices to deliver high-quality results. Eager to collaborate with multidisciplinary teams to drive impactful outcomes in the medical field.

Overview

15
15
years of professional experience

Work History

Specialist (Role: Technical Manager)

TATA Elxsi Limited
08.2022 - Current
  • Expert in reviewing and providing high quality Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Summary of Safety and Clinical Performance (SSCP) in compliance with MEDDEV 2.7/1 Rev. 4 and EU MDR.
  • Experience in Post-Market Surveillance Plans (PMSP), Periodic Safety Update Reports (PSUR) and Post-Market Clinical Follow-up Evaluation Reports (PMCFERs).
  • Working as a project/technical manager for a team of 12 members (including medical writers, senior medical writers, specialists, and reviewers) and overseeing the performance of each member.
  • Having experience with custom-made medical devices and patient-matched medical devices clinical documents (CEP, CER, and SSCP), I led the team of five members for this project.
  • Active communication with clients.
  • Allocate tasks to the team members.
  • Make sure that all the deliverables are done timely, and the entire team is working efficiently.
  • Working closely with the Clinical Affairs and Cross-Functional Teams to ensure safety and standards, with regard to clinical evaluation transparency for the assigned products.
  • Creating granular plans for all deliverables.
  • Follow up on missing documents, inputs, and pending queries in a timely manner.
  • Monitor the progress of ongoing files internally and externally in daily sync-up meetings with the CER team based on the detailed plan created by us.
  • Proactively flag input delays and potential impacts on the schedule to respective stakeholders.
  • Conduct regular trend analysis of errors to monitor the team's performance.
  • Conveys the critical information and discussion points from each weekly status report to the respective SMEs and writers.
  • Regularly conduct quarterly check-ins and give constructive feedback to the team based on their inputs.
  • Map the resources to the files to be started, in progress, and in the pipeline.
  • Ensuring 100% utilization of all the resources.
  • Identify ad hoc tasks for resources if project-related work is not available.
  • Ensure an appropriate backup plan for emergency situations.
  • Enhance team competency at all levels to promote independent work.
  • Received customer appreciation awards from the client.

Specialist

CLINCHOICE PVT LTD
04.2020 - 08.2022
  • Writing and reviewing of high-quality of Clinical Evaluation Plans (CER), Clinical Evaluation Reports (CEP) and Summary of Safety and Clinical Performance (SSCP) in compliance with MedDev 2.7.1 Rev 4 and EU MDR.
  • Review the technical documents relevant to target device and update in the CER
  • Screening and identifying articles based on inclusion/exclusion criteria
  • Drafting literature summaries for target device and alternative devices
  • Review literature to elucidate the clinical problem and current treatment techniques
  • Study and report device characteristics and instructions for use
  • Identify the Alternative treatment procedure for target device and evaluate the data
  • Identify and evaluate the data of medical fields concerned for the target device
  • Summarize post-marketing surveillance and risk management data for the target device
  • Draft the SOA (state of the art) section using medical fields concerned for the target device, disease background, and alternative therapies.
  • Review and summarize equivalence literature data, if equivalence is claimed.
  • Having experience in Endnote tool usage
  • Train and mentor new writers and perform detailed reviews of deliverables.
  • Conducting team meetings and clarifying the questions, if required

Technical Lead

HCL TECHNOLOGIES LTD
10.2018 - 04.2020
  • Review and submission of high-quality of Clinical Evaluation Reports (CER), and Clinical Evaluation Plans (CEP) in compliance with MedDev 2.7.1 Rev 4 and EU MDR. Also perform gap analysis, if required.
  • Worked as a technical lead for a team of 8 members (including medical writers, senior medical writers, reviewers) and overseeing the performance of each member
  • Review the technical documents relevant to target device and update in the CER
  • Identify the keywords and prepare the literature search protocol for the target device
  • Proficiency in performing literature search using PubMed, google scholar and Ovid databases
  • Experience in searching databases such as FDA MAUDE, FDA Recall, MHRA, SATP, BfArm etc.
  • Screening and identifying articles based on inclusion/exclusion criteria
  • Drafting literature summaries for target device and competitor devices
  • Review literature to elucidate the clinical problem and current treatment techniques
  • Study and report device characteristics and instructions for use
  • Identify the Alternative treatment procedure for target device and evaluate the data
  • Identify and evaluate the data of medical fields concerned for the target device
  • Summarize post-marketing surveillance and risk management data for the target device
  • Appraise the literature data using appraisal criteria
  • Draft the SOA (state of the art) section using medical fields concerned for the target device, disease background, alternative therapy and competitor device information.
  • Review and summarize equivalence literature data, if equivalence is claimed.
  • Having experience in Endnote tool usage
  • Train and mentor junior writers and perform detailed reviews of deliverables
  • Conducting team meetings and clarifying the questions, if required
  • Active participation in client calls
  • On daily basis, assigning the tasks to the team members
  • Feedback will be given to the team members after reviewing CER

Senior Drug Safety Associate (Pharmacovigilance)

Accenture
06.2010 - 09.2018
  • Diligently keeping view on Client Database (ARGUS) for a new case to process
  • Reviewing and Drafting narratives for literature, post marketing studies, clinical trials phases 1 to 3 and spontaneous reports.
  • Reporting the case to respective regulatory authorities.
  • Experience in Literature review of the medical/regulatory/Pharma documents.
  • Experience in labelling assessment by reviewing the investigator brochure.
  • Having baseline knowledge on aggregate reports like Periodic Benefit Risk Evaluation Reports (PBRER), Periodic Safety Update reports (PSUR), scientific writing, clinical study reports review, investigator brochure review and protocol review.
  • Working on SAE reconciliation Study reports by comparing clinical and safety data base. Conducting sessions to the team members based on errors identified in the reconciliation.
  • Perform daily responsibilities in accordance to all applicable Standard Operating Procedures (SOP), conventions and client polices.
  • Clarifying the doubts with physicians whenever required.
  • Engaging in planning, organizing, and managing daily work to meet service level timelines, deliverables and regulatory timelines.
  • Effectively segregating cases received from the client daily during start of the day
  • Giving training to the new joiners on the process.
  • Performing quality check and sending errors to the respective member.
  • Collating all the process errors every month and giving presentations to the team members.
  • Collating all the process updates every weekend and giving presentations to the team members.
  • Clarifying the process doubts whenever team required.
  • Attending project team meetings and client calls
  • Won Numero Uno Awards within process

Education

B. Pharmacy -

Sri Venkateshwara College of Pharmacy
01.2008

XII - undefined

Nalanda Junior College
01.2004

X - undefined

Bharathi Vidya mandir
01.2002

Skills

Development of clinical evaluation plans

Disclaimer

I hereby affirm that the particulars furnished above are true to the best of my knowledge. Place: Hyderabad Date: v.sripathi

PROFILE SUMMARY

  • Overall, 15 years of professional experience in Medical Writing and Pharmacovigilance domain.
  • Experience in writing and reviewing of Clinical Evaluation Reports (CER) for Medical Devices as per guidelines mentioned in MEDDEDV 2.7/1 rev 4, MDD and MDR (Medical Device Regulation).
  • Experience in drafting and reviewing of Post-Market Surveillance Plans (PMSP) and Periodic Safety Update Reports (PSUR)
  • Currently Leading the team of 12 members of medical writing team.
  • Currently working as a Specialist (Role: Technical manager) in Tata Elxsi Limited, Hyderabad Since Aug 2022 to till date.
  • Worked as a Specialist - Medical Writing in ClinChoice Pvt Ltd. (formerly known as IMED GLOBAL SOLUTIONS PVT LTD), Hyderabad Since April 2020 to August 2022.
  • Worked as a Technical Lead (Medical writer) in HCL Technologies, Chennai from October 2018 to April 2020.
  • Worked with Accenture as a Senior Drug Safety Associate (Pharmacovigilance) from June 2010 to September 2018.

Timeline

Specialist (Role: Technical Manager)

TATA Elxsi Limited
08.2022 - Current

Specialist

CLINCHOICE PVT LTD
04.2020 - 08.2022

Technical Lead

HCL TECHNOLOGIES LTD
10.2018 - 04.2020

Senior Drug Safety Associate (Pharmacovigilance)

Accenture
06.2010 - 09.2018

XII - undefined

Nalanda Junior College

X - undefined

Bharathi Vidya mandir

B. Pharmacy -

Sri Venkateshwara College of Pharmacy
Sripathi VattikutiTechnical Manager - Medical Writing