Dr. Kishore Guguloth
Medical Writing- Specialist
Hyderabad
Summary
Forward-thinking Medical writer/ Reviewer bringing 9.5 years of expertise in Medical Writing, Clinical Evaluation Report – (CEP, CER, BER, LSR, PMSP, PSUR, SSCP, PMCF plan, PMCF report) sector businesses. Cultivates rapport with individuals to optimize project goals and output, resolve complex problems and deliver innovative improvement strategies. Proficient in EU MDR 2017/745, MEDDEV 2.7.1 rev.4.
Overview
9
9
years of professional experience
Work History
Specialist
TATA Elxsi
9 2022 - Current
- Detailed Analysis of European regulatory requirements (EU-MDR)
- High-level documentation experience with the regulatory documents like Clinical Evaluation- CEP and CER, BER (Biological Evaluation), SSCP (patient and healthcare professional), PMS plan and report (Sales and complaints), PMCF plan and Report, writing and review
- Responsible for conducting training for the team and handling client meetings
- Responsible for maintaining the project trackers and timely submission of the deliverables as per the agreed timelines.
Team Lead
Celegence Systems Pvt. Ltd
09.2019 - 08.2022
- Responsible for writing and reviewing CERs from MEDDEV 2.7.1 Rev 4 format to MDR updates and initial MDR CERs for new products
- Responsible for writing Clinical Evaluation Plan (CEP) and Literature Search Report (LSR) for MDR CERs
- Responsible for developing and reviewing the post-market clinical follow-up (PMCF) plan and PMCF report
- Responsible for developing and reviewing post-market Surveillance (PMS) plans and Reports
- Responsible for review of periodic safety update reports (PSURs)
- On-time development and delivery of various sections of high-quality regulatory documents compliant with MEDDEV 2.7/1 Rev.4 and MDR for Medical Devices across therapeutic areas
- Good knowledge of searching databases (Ex: PubMed, Cochrane, Prospero, Embase, US Clinical Trials, EU Clinical Trials, and WHO Trials databases) for Device under Evaluation (DUE) Literature and State of the art (SOTA) Literature
- Good Knowledge of Adverse Event Search databases (Ex: MAUDE, TPLC, Recalls, BfArM, Swissmedic, MHRA, TGA, etc.)
- Proficiency in comprehending scientific data and medical terminology and efficiently summarizing information from source documents and published literature
- Responsible for complete handling of projects and maintaining project-related trackers
- Responsible for conducting training for the team and handling client meetings.
Lead Engineer
HCL Technologies PVT. LTD
04.2018 - 09.2019
- Responsible for planning and execution of the CEP and CEP Tool, Stage 0 of the CER
- Responsible for writing and reviewing CER (stages 1 to 4)
- Responsible for drafting the MEDDEV 2.7.1 Rev 3 CER to Rev 4 updates
- Updated a few MEDDEV 2.7.1 Rev 4 CERs to comply with MDR Guidelines
- Responsible for complete writing of CERs within the business schedule in accordance with local procedures, client guidelines, and regulatory requirements
- Responsible for Drafting State of the Art (SOTA) sections for the assigned CERs
- Responsible for documents drafted in accordance with procedures and internal and external guidelines (e.g., MEDDEV 2.7.1 rev four and MDR).
Executive- Medical writer
IMED Global Solutions India PVT. LTD
10.2017 - 04.2018
- We plan and execute general medical writing activities and systematic literature reviews to generate CER for assigned therapeutic areas and projects within the client's Global R&D Medical Device sector
- Work closely with other Medical Operation Team members including Medical Directors, and Project Managers to interpret clinical data from medical and scientific literature during the systematic literature review process's screening and data extraction steps using software (Distiller SR)
- Extracts data from included studies, interpret study results, synthesizes literature, and prepares summaries into formal reports
- Responsible for the CER files are linked to appropriate Quality Systems and Regulatory documents (e.g., Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed
- Supports and acts as an SME during audits and inspections pertaining to CER processes and reports.
Clinical Safety Associate-I
LAAN RESEARCH PVT. LTD
12.2014 - 10.2017
- Perform reviewing and writing initial and annual update CER for medical devices to evaluate continued safety and performance
- It includes appraisal and analysis of identified clinical data, given the benefits and risks involved
- Prepares, writes, and edits creditable systematic literature reviews by creating protocols and reports to synthesize and analyse the clinical data from medical and scientific publications reporting on various medical devices
- Timely submission of the regulatory documents according to the guidelines
- Responsible for documents produced per procedures and internal and external guidelines (e.g., MEDDEV 2.7.1 Rev. 3 & Rev. 4)
- Handle responsibilities of developing concise, accurate, and medically relevant safety narratives per regulatory requirements
- They perform quality reviews and check cases for accuracy, consistency, and compliance of data entered in various fields in source document processing and narrative writing
- Create and maintain workflow trackers, flow charts, and PowerPoint presentations as needed.
Education
Doctor of Pharmacy (Pharma-D) -
Vaagdevi college of pharmacy, MGM Hospital (Kakatiya university)
B. Pharmacy - undefined
Sri Balaji college of pharmacy, Karimnagar (Kakatiya university)
Intermediate - undefined
Geethanjali Junior College
SSC - undefined
Gnana Mandir High School
Skills
Good Knowledge of CEP, CER, BER, LSR, PMS, PMCF, SSCP and PSUR writing and Review
Sound Knowledge of MEDDEV 271 Rev 3, Rev 4 guidelines, MDR 2017/745 regulations, QMS ISO 13485, and a good understanding of IVDR 2017/746
Sound Knowledge in Literature search and AE databases like PubMed, Embase, Prospero, Cochrane Library, OVID database, US Clinical Trials, EU Clinical Trials, WHO Clinical Trials, MAUDE, TPLC, BfArM, Swissmedic, MHRA, TGA, SFDA etc)
Good knowledge of databases like Distiller SR and CAPTIS Literature databases
Good knowledge of reference databases like Endnote and Zotero
Publications
- Pattern of thermal burn injuries and their outcomes at burn care unit of MGM hospital, Warangal, Andhra Pradesh, India in international journal of pharmaceutical sciences (Vol. 3 (6) | 288-295).
- Assessment of quality of life in thermal (flame) burn patients: an observational study at a tertiary care teaching hospital in Warangal, A.P., India in international journal of pharmaceutical sciences (IJPLS) [Vol.4 (7) Dec 2013, 3151-3158].
- Assessment of psychological status in patients with thermal (flame) burns at a tertiary care teaching hospital in Warangal, A.P., India in International Journal of Community Pharmacy [Vol. 6 (2), May– August 2013, 18- 25].
Disclaimer
I declare that the above information is accurate and correct to the best of my knowledge and belief.
Timeline
Team Lead
Celegence Systems Pvt. Ltd
09.2019 - 08.2022
Lead Engineer
HCL Technologies PVT. LTD
04.2018 - 09.2019
Executive- Medical writer
IMED Global Solutions India PVT. LTD
10.2017 - 04.2018
Clinical Safety Associate-I
LAAN RESEARCH PVT. LTD
12.2014 - 10.2017
Specialist
TATA Elxsi
9 2022 - Current
Doctor of Pharmacy (Pharma-D) -
Vaagdevi college of pharmacy, MGM Hospital (Kakatiya university)
B. Pharmacy - undefined
Sri Balaji college of pharmacy, Karimnagar (Kakatiya university)
Intermediate - undefined
Geethanjali Junior College
SSC - undefined
Gnana Mandir High School
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