Ravikumar P T

• Authoring and Reviewing medical writing clinical evaluation report (CER), Post Market Surveillance (PMS) -PMS Plans, Periodic safety update report (PSUR), Post Market Clinical Follow-up (PMCF) Activities as per EU MDR guidelines.
• Familiar with ISO 13485, ISO 14971, 21 CFR 820, IEC 60601
• Authoring Standard Assessment Activity and Design verification summary report for medical devices.
• Conducts strategic assessment (gap analyses) of information needs within the therapeutic area and develops fulfillment strategies (e.g., Publication/research planning, educational activities, attendance at key medical meetings and advisory boards, etc.).
• Screen and summarize literature for relevant clinical data
• Review literature to elucidate the clinical problems and current treatment techniques.
• Experience in web technical writing, web usability (UX) practices, product documentation, or online publishing, preferably focusing on developer-centric content.
• This includes researching and synthesizing pages of technical product documentation source materials and translating those into digestible content.
• Working knowledge of HTML, Markdown, or DITA XML for the purposes of drafting and writing technical content within a technical CMS environment.
• Writing within a style guide or following a set of standards for the writing, formatting, and designing of web-based documents.
• Making Literature strategies, review, screening, appraisal, conclusion, and summarization of data.
• Literature Search through Ovid database (consist of Embase and Medline).
• Familiar with use of databases like PubMed, Ovid, Medical conference sites.
• Study and report device characteristics and instructions for use and Evaluate data for similar competitor devices
• Summarize post marketing surveillance and risk management data for the target device.
• Collecting, harmonizing, analyzing, interpreting, and reporting medical science research findings in appropriate manner to support production of documents such as: Clinical and non-clinical documents/reports, regulatory documents/reports, scientific reports.
• Clinical and non-clinical study documents, overviews and summaries of safety and efficacy, drug benefit-risk assessment reports, etc.
• Well versed with usage of MedDRA (version 21.1) terminology, Literature search tools, ICH, GCP, FDA and EU guidelines for documentation.
• Gap assessment, remediation of clinical evaluation report, writing clinical evaluation plan (CEP), clinical evaluation report (CER), PSUR for medical devices from MEDDEV rev 4 to MDR.
• Clinical Evaluation Reports, Post Market Surveillance (PMSP, PSUR and PMCF Plan for Software Medical device (SAMD) as per MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software.

Project Management activities:

• Proposal Deck preparation
• Project Kick of Deck preparation
• SOW Preparation
• Purchase order and Project Report creation
• Resource Allocations, Resource attendance approvals, Leave approvals.
• Vendor SOW review and updating according to Customer approved SOW.
• Team Handling, assigning daily activities to team, Reviewing the team task assigned by customer
• Teams’ Weekly status Report updating to Customer and query resolution.
• Optimized resource utilization by accurately forecasting project needs and allocating resources accordingly throughout the project lifecycle.
• Improved overall team performance by conducting regular performance evaluations and providing constructive feedback to facilitate professional growth.
• Partnered with project team members to identify and quickly address problems.
• Ensured timely delivery of critical deliverables by closely monitoring progress against milestones and adjusting plans as necessary.
• Developed comprehensive project plans that clearly outlined objectives, timelines, budgets, risks, and success metrics for all stakeholders.
• Enhanced client satisfaction by consistently delivering high-quality projects within budget and on schedule.
• Balanced multiple projects simultaneously, maintaining focus on priorities and deadlines.
• Led cross-functional teams to streamline project delivery, ensuring alignment with client expectations.
• Coordinated with stakeholders to define project scopes, aligning objectives with business goals.
• Implemented technology solutions to automate repetitive tasks, boosting team productivity.
• Tracked project and team member performance closely to quickly intervene in mistakes or delays.
• Monitored project progress, identified risks and took corrective action as needed.
• Recruited and oversaw personnel to achieve performance and quality targets.
• Reported regularly to managers on project budget, progress, and technical problems.

• Medical writing clinical evaluation report (CER), PSUR, PMS Plans, PMS Report, PMCF Activities as per EU MDR guidelines - Karnataka, Bangalore, Primary and Secondary Authoring of Clinical Evaluation Reports, Post Market Surveillance, Post Market Clinical Follow-up Plans, Summary of Technical Documents, PSUR, PMSR, PMCF Report
• Making Literature strategies, review, screening, appraisal, conclusion, and summarization of data
• Literature Search through Ovid database (consist of Embase and Medline)
• Familiar with use of databases like PubMed, Ovid, Medical conference sites
• Collecting, harmonizing, analyzing, interpreting, and reporting medical science research findings in appropriate manner to support production of documents such as: Clinical and non-clinical documents/reports, regulatory documents/reports, scientific reports
• Clinical and non-clinical study documents, overviews and summaries of safety and efficacy, drug benefit-risk assessment reports, etc
• Clinical Evaluation Reports, Post Market Surveillance (PMSP, PSUR and PMCF Plan for Software Medical device (SAMD) as per MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software.

• Triage - Initial receipt, database searches as necessary registry, Triage of incoming cases to determine seriousness for prioritization of daily workflow
• Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, and expectedness/listed/labelled); special scenarios; product complaint information; reportability with due date; and accuracy and consistency
• Based on assessment of cases, process accordingly
• Completion of literature searches as necessary
• Case processing (Data Entry, Coding, Labelling and Narrative) - Spontaneous, literature, clinical trial Serious Cases including mail correspondence and review of mails and PVP consultation
• Quality review – Review of cases for errors in processing and provide feedback through forms (new hire feedback form, triage feedback form and quality review feedback forms) in quality control tool
• Mentoring/Lead - Trained the new hires (40+ New Associates) on all product specific conventions
• Worked in various therapeutic teams OTC (over the counter drugs) and specific product teams
• Clarification of unclear or illegible information from the local safety officer or call center and customer communication as per the project requirement
• Review and make suggestions for system and procedure enhancements and participation in inspection and audits as required and participation in business continuity plan as required
• Team Responsibilities:
• Consolidating all the Quality data in the team and maintaining the tracker, resolving the issues
• Conduct QRTT sessions to discuss the errors identified during the Quality review of cases
• Assisted team for all the updates and helped in implementation process
• Attended client calls for the subject and error discussion
• Preparation of Minutes of meeting in daily huddles and circulating among the team
• Training sessions for the new batches on product coding and event coding
• Subject Matter Expert (SME) for Product Quality Complaints (PQC) and Narrative writing.

• Worked to improve therapeutic care provided to patients by monitoring the patient daily
• Participated in ward rounds along with physicians
• Identified and reported adverse drug reactions
• Monitored prescriptions and identified drug and dosing errors
• Counselled patients on appropriate usage of medications as well as management of various diseases
• Registrations:
• Registered Pharmacist in Karnataka State Pharmacy Council