E CLINAL WORKS
Dr.R.S.SARAVANAN
Doctor
Chennai,TN
Summary
Experienced and detail-oriented Medical Scribe with 14 years of experience in providing comprehensive documentation support to healthcare providers. Proficient in accurately transcribing patient histories, physical examinations, and treatment plans in real-time, with a deep understanding of medical terminology and electronic health record (EHR) systems. Adept at managing administrative tasks, ensuring compliance with HIPAA regulations, and contributing to improved clinic efficiency and patient care. Demonstrated ability to work collaboratively with medical professionals and train new staff, enhancing overall team performance. Committed to maintaining the highest standards of accuracy, confidentiality, and patient-centered care.
Overview
12
12
years of professional experience
Work History
Medical Scribe
Omega Health
10.2022 - 12.2023
- Real-time Documentation: Accurately and efficiently transcribed patient medical histories, physical examinations, and other relevant information during clinical visits with USA doctors.
- Electronic Health Records Management: Updated and maintained electronic health records (EHR) with diagnostic test results, treatment plans, and follow-up instructions, ensuring all data was precise and up-to-date.
- Patient Interaction: Assisted healthcare providers by documenting the details of patient encounters in real-time, allowing physicians to focus on direct patient care.
- Administrative Support: Managed administrative tasks such as scheduling appointments, coordinating referrals, and processing paperwork to ensure a smooth patient flow.
- Compliance: Ensured compliance with HIPAA and other privacy regulations by safeguarding patient information and maintaining confidentiality at all times.
- Collaboration: Coordinated with physicians, nurses, and other healthcare professionals to ensure the quality and accuracy of documentation, enhancing overall clinic efficiency.
- Training: Provided training and support to new scribe hires on EHR systems and best practices, contributing to a knowledgeable and proficient team.
Clinical Associate Manager/ Specialist
Stryker (Contractor)/ Tata Elxsi
02.2021 - 10.2022
- Lead with Consulting with TA lead, SME for the Safety of the Pharma product as needed for cases requiring additional safety information with Safety of the product
- Leading the team of ICSR (Individual Case Safety Report), Case processing & Literature for Regulatory submission, business unit ensuring compliance with global regulations, internal procedures
- Identify and communicate any discrepancies, errors, or non-compliance issues to the relevant teams
- Verify data consistency between text and tables, ensuring proper formatting, and validating reference citations
- Drive the clinical interpretation of complex data and information and condense it into clear, concise & accurate messages that address customer information requirements
- Strategic planning for business development and expansion of client base in multiple regions
- Managing, leading with a subject matter expert in handling the resources for Clinical evaluation with Pharma products for PMS, PMCF, PMSR, PSUR & Literature activities with Pharmaceutical products & drug coated devices and Complaints projects with editing, review, coordinate, and complete the regulatory documents supporting clinical development/product registration
- Assist complaint investigators, Risk Management File Maintenance & regulatory reporting as necessary with developing and maintaining the Survey database
- Handling the activities of the Feedback, complaints form with complete analysis of the new site for all the Registry studies with direct interaction with the stake holders within India & across the Globe
- Managing budget and preparing cost estimation for medical affairs projects
- Preparing SOW’s, PMP and providing technical inputs for new accounts
- Expertized in review in the global safety database for accuracy, completeness, and consistency with the source documents, with supporting the Clinical trial of Phase I to IV with different site monitoring
- Interacts with multiple departments within the team and with R&D, Engineering and other teams
- Expertise in Medical device & Pharmacovigilance process by reviewing each activity in the global safety database for accuracy, completeness, and consistency with the source documents
- Assisted medical safety lead in monitoring the safety profile of products including with activities such as literature review, medical review/evaluation of individual cases or signal detection
- Performed review of ongoing literature safety surveillance for marketed and investigational products
- A SME (Subject Matter Expert) making things inline with the identification of ICSRs from literature, evaluation of events for signal management & during Audit & Inspection
- Performing risk management and risk analysis activities with gap assessment for labeling requirement as per Risk Management of ICH GCP, ISO 13485, EU MDR/IVDR
- Writing and drafting Technical documents & GSPR as per EU MDR 2017/745 Annex I
- Ensured timely production and review of CER and post marketing surveillance reports (PSUR, PMS Plan, and PMSR)
- Provided weekly and monthly status reports to the higher management & maintained metrics for productivity and quality
- Assisting, preparing, submitting and obtaining approval of the submission documents to IRB/IEC/Third body/Regulatory Authority in accordance with local requirements
- Managed budget for medical safety writing program and prepared cost estimation for projects
- Managing all Project related work with Team Lead activities for the current business transformation with AI technologies
- Medical writing for CEP/CER/PER, PMS & PMCF report with Literature review for both Pharma & device.
Senior Medical writer
L&T
10.2019 - 09.2020
- Performing risk management and risk analysis activities with gap assessment for labeling requirement as per EU IVDR/MDR
- Writing PER/PMS/PMPF reports from scratch for all Class A, B, C & D devices
- Subject matter expert- Medical devices clinical evaluation (MedDev Rev 4 and EU-MDR)
- Building new teams by providing training in scientific writing, MEDDEV 2.7/1 Rev
- 4, MDR and other related topics and take up all new/pilot projects, deliver them successfully and make the team less dependent
- Literature search, writing and reviewing scientific and regulatory documents such as Performance Evaluation Report (PER), Clinical Risk-Benefit Analysis (CRBA), Post Market Surveillance Report (PMSR), Periodic Safety Update Report (PSUR), Manuscripts, Newsletters, Slide Decks, PI, Posters, Newsletters, etc
- Experience in searching databases such as FDA MAUDE, FDA Recall, MHRA, SATP, BfArM etc
- Trainer/Mentor and providing training for new interns
- Identifying the keywords and preparing the literature search protocol for the target device with proficiency in performing literature search using PubMed, Springer, Cochrane, Google scholar and Ovid databases of inclusion/exclusion criteria.
Lead Engineer
HCL Technologies
05.2018 - 06.2019
- Collaborate with senior scientific staff to design, implement, and interpret the data from development projects
- Early point of contact with Customer key relationship builder with supporting Business of all the projects
- Clinical Benefits and Contraindication analysis with Risk/Benefit analysis with direct interaction with Physician & client
- Literature search, writing and reviewing scientific and regulatory documents such as Clinical Evaluation Report (CER), Clinical Risk-Benefit Analysis (CRBA), Post Market Surveillance Report (PMSR), Periodic Safety Update Report (PSUR), Manuscripts, Newsletters, Slide Decks, PI, Posters, etc
- Experience in searching databases such as FDA MAUDE, FDA Recall, MHRA, SATP, BfArM etc
- Review literature to elucidate the clinical problem and current treatment techniques
- Appraise the literature data using appraisal criteria
- Drafting SOTA (state of the art) section using medical fields concerned for the target device, disease background, alternative therapy & competitor device information
- Identify the Alternative treatment procedure for target device and evaluate the data
- Summarizing post-marketing surveillance and risk management data for the target product & device.
Senior Medical writer
Lakshmana Hospital
06.2012 - 01.2018
- Experience in Hospital sector with clinical field working as a Duty Medical Officer by handling patients in both Outpatient and Inpatient department with complete knowledge in the field of Medicine
- To support investigators for EC submission and query resolution with preparation & conduction of Site Initiation Visits
- Documented Medical history of over many patients & records with Archival.
Medical Analyst
Accenture
06.2013 - 06.2016
- Performed quality reviews and quality projects in Audit pursue with timelines for all Fatal, Serious, and Non-Serious cases with taking trainings with Case processing by doing all cases from Fatal, Serious, and Non-serious NIS (Non-interventional cases), POP (Patient support program), SR (Spontaneous report), HA (Health authority cases) and Special project
- Provide Medical review with Medical assessment device with reporting responsibilities for Regulatory submission
- Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines
- Expertise in case processing and LISA application with Posters, Publications for screening of valid ICSR globally
- PMS/PMCF expertise for all class of devices by analyzing PMS review data with CAPA
- Performed analysis on the RCA and CAPA (for process improvements and reduction of error in the documents) with team members to resolve the findings
- Performed confirmation on accuracy of data, consistency with available source documents with regulatory documents, Source documents, CIOMS, line listings with internal Work practice, Standard Operating Procedure and Client SOP
- An expert in Case processing, Literature processing and Literature search dealing with AEAN (Adverse event analyst) with complete ICSR and Sigdet (Signal detection) analysis for data basing valid cases of Fatal, Serious and Non-serious cases and Clinical data management
- Completely trained in LiSA (Literature Search Application) in analyzing AEAN (Adverse event analyst) with SIAN (Signal analyst) for Springer and Non-LiSA articles with writing Literature Case Processing cases
- Wrote RCA (Route cause analysis of late cases with cause, responsibility, and prevention by making CAPA (Corrective and preventive action) for Literature and Case Processing.
Education
PG in Clinical Research and Clinical Trial Management -
Apollo Hospital & Research Centre
Bachelor of Homeopathic Medicine and Surgery - undefined
Government Homoeo Medical College
HSC - undefined
Southern Pearl Matric Higher Secondary School
SSLC - undefined
Southern Pearl Matric Higher Secondary School
Skills
Patient history understanding
Medical Abbreviations Knowledge
HIPAA Compliance Knowledge
Strong Communication Skills
References
- Vignesh, 8148336747
- Brabin, 9962084838
Disclaimer
I hereby declare that, the information provided above is true to my knowledge of confirmation.
Software
SEQUEL MED
ARISG
ARGUS
Timeline
Medical Scribe
Omega Health
10.2022 - 12.2023
Clinical Associate Manager/ Specialist
Stryker (Contractor)/ Tata Elxsi
02.2021 - 10.2022
Senior Medical writer
L&T
10.2019 - 09.2020
Lead Engineer
HCL Technologies
05.2018 - 06.2019
Medical Analyst
Accenture
06.2013 - 06.2016
Senior Medical writer
Lakshmana Hospital
06.2012 - 01.2018
PG in Clinical Research and Clinical Trial Management -
Apollo Hospital & Research Centre
Bachelor of Homeopathic Medicine and Surgery - undefined
Government Homoeo Medical College
HSC - undefined
Southern Pearl Matric Higher Secondary School
SSLC - undefined
Southern Pearl Matric Higher Secondary School
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