Pavani Vangala
Raichur,India
Summary
To secure challenging and rewarding position that will allow me to utilize my broad blend of technical, analytical and creative skills, so that I may continue to grow by expanding and strengthening my knowledge related to the medical device industry that will redefine for the benefit of public and will provide scalable solutions to unique problems.
Overview
5
5
years of professional experience
Work History
Associate Scientific Writer
Indegene Pvt Ltd
03.2021 - 11.2025
- To write the clinical evaluation reports and also review them accordingly as per the MEDDEV 2.7/1 Rev. 4/ MDR
- Author complex CERs on sections that require critical analysis and summarization of safety and device performance data.
- To analyze the clinical data from medical and scientific publications reporting on a range of medical devices
- Performing systematic gap analysis of Clinical Evaluation Report(s) & preparation of CER Assessment reports with recommendation/remediation steps as per EU MDR
- Training junior medical writers on literature search, evaluation of clinical data, and summarizing the literature based on the requirements.
- To review CEP/CER/CEP/PSUR/PMCF/SSCP/CIP/LMR
- Hands on experience in patient narratives and drafting CSR
- Developing Internal SOPs, Templates etc.
- To perform the literature search using various databases and summarizing them accordingly
- Hands on experience in Endnote and distiller tool
- Proficiency in performing literature search using various databases such as OVID/ EMBASE
- Participates in core process steps for systematic literature reviews including search, screen, data extraction, analysis, and synthesis of the literature for CER processes
- Extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports
- Critically appraising scientific literature and writing summaries for articles, products and surgical procedures
- Acquires or possesses in-depth knowledge of competitor devices, state-of-the-art, current clinical/market developments, literature review processes
- Conducts proofreading, editing, document formatting, review
- 4 years, 8 months
Education
Pharm D - Doctor of Pharmacy
N.E.T Pharmacy college
Raichur, Karnataka01.2020
10+2 - PUC
Sri Chaitanya Junior College
Bellary01.2013
SSC - undefined
St. Xavier school
Manvi01.2011
Skills
- Clinical evaluation reports
- Literature review processes
- Data extraction and analysis
- Regulatory compliance
- Database proficiency (OVID/EMBASE)
- Distiller tool utilization
- Proofreading
- Manuscript preparation
Languages
English
Hindi
Telugu
Kannada
Declaration
I here by declare that the above mentioned information is true to the best of my knowledge and belief. Yours Sincerely Dr. V. Pavani
Therapeutic areas worked
- Neurovascular: Class of device III, Successfully completed CER/CEP/Literature search/data extraction for following devices: Flow diverters, Microcatheters, Coils, stent retriever, Guidewires.
- Ophthalmology: Class of device I, IIa, IIb, Worked on following products: Alcon Laboratories/ CIBA Vision (Clear Care Cleaning and Disinfecting Solution) OPTIFREE RepleniSH with TearGlyde, Optifree Puremoist, Clear Care solutions, OPTI-FREE EXPRESS, Aquify Multi-Purpose Solution, Abbott Medical Optics/Allergan COMPLETE Revita Lens, RevitaLens OcuTec AvizorUnicaSensitive
- Spinal: Class of device III, Worked on following devices Spinal cord stimulators across various indications
Timeline
Associate Scientific Writer
Indegene Pvt Ltd
03.2021 - 11.2025
Pharm D - Doctor of Pharmacy
N.E.T Pharmacy college
10+2 - PUC
Sri Chaitanya Junior College
SSC - undefined
St. Xavier school