Sumithra Prathipati
Morton,IL
Summary
Highly analytical professional with comprehensive experience managing post-marketed products across therapeutic areas, including oncology, clinical aspects of nervous, immunology, renal/cardiac systems, with regulatory compliance, reporting on quality control (QC) and routing cases to appropriate workflows and writing skills. Skilled in medical review of ICSRs, authoring monthly reports (MSSR) and PBRERs, Signal detection & Validation activities while conducting case processing, conducting medical reviews, reading safety reports and working with drug safety databases, concise medical assessments SDEAs, defining quality compliance and control measures, vendor management, and adverse events reporting engaging in cross-functional collaboration with medical information for the intake and processing. As a member of the team, provided clinical, and pathophysiological expertise to the assigned complying to the global regulatory requirements. Possess deep dive understanding of global regulatory authority guidelines for post-marketing drug safety surveillance, and clinical assessment of the patient populations and responsible for both clinical and administrative/business functions relating to their assigned projects. Adept at evaluating quality and integrity of reported data and site efficacy. Proficient in developing patient recruitment strategies to meet enrollment timelines, INDs, Protocols, while ensuring deliverables and vendor compliance.
Overview
8
8
years of professional experience
Work History
Physician Medical Reviewer
Altria
01.2023 - Current
- Responsible for performing in PSI’s governing commercial efforts related to medical coding, responsible for providing senior level leadership in all assigned activities including, but not limited to providing leadership activities, consulting with clinically oriented clients, supporting recruitment of team members, performing SAE reconciliation, quality control deliverable, informatics, supporting client and industry presentation
- Trailing clients to Trackwise digital activities in adverse event survey data and presenting with appropriate coding convention to AEs reported
- Sound knowledge of pathophysiology and clinical pharmacology and therapeutics (CPT) of product
- Determining appropriateness of reported causality assessment
- Consult with assigned clients in development, implementation, and maintenance of SOPs
- Responsible for review of Individual Case Safety Reports (ICSRs)
- Ensure completeness and accuracy of safety information in ICSR through assessment of seriousness, expectedness, causality, MedDRA coding, review of narrative summary and provide case comments; provide medical inquiries for follow-up
- Provide medical input for analysis of Periodic Safety Update Reports, Expert Statements, Risk Management Plans, and other aggregate reports where appropriate, draft components
- Executed activities including technical writing, investigation support (root cause analysis/impact assessment), project representation
- Procedures in accordance with customer standards and models of best practice in industry
- Assess complexity of proposed client coding efforts including projection of resource requirements to defined against specified KPIs
- Perform monthly AE line-listing review to identify SUSARs, issues and inconsistence of event term capture and coding, and seriousness, expectedness and causality assessments
- Provided high-level expertise in MedDRA and other coding dictionaries, inputs in information technology infrastructure as it relates to medical coding projects.
Pharmacovigilance Scientist (Signal Detection)
Pro Pharma Group
10.2021 - 12.2022
- In collaboration with the client, had the opportunity to collaborate and demonstrate the safety concepts, global regulatory reporting obligation documents, vendor management working with PV Safety Data Exchange agreements for the products
- Having proficient working knowledge in Signal Detection, Validating the emerging safety observations (Myocarditis, Pericarditis, Paraesthesia, and Migraine) along with the required literature search
- Ensured representation of safety surveillance issues and AESIs with accuracy and evaluation
- Assist in identifying appropriate risk windows in published literature to be used in O/E if requested by the biostats team including literature search for alternative risk windows for the current AESIs, or risk window(s) for AEs being added to global OE analyses
- Conducting periodic effectiveness check for the CAPAs, queries during audits that are implemented to ensure compliance with SOPs by maintains tracking tools for departmental key performance/quality indicator metrics
- Prepared medical writing/analysis, and post-marketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety observations across various regulatory safety documents for assigned products both periodic and ad hoc
- Drafted the validation reports of the emerging safety observations (Myocarditis, Pericarditis, Paraesthesia, and Migraine) along with the required literature search, let to label updating with identification, analyzing and concluding the safety on cumulative trends
- Drafting signal assessment reports for AE across various therapeutic areas following a thorough review of the various sources of safety information
- Lead and participated on Safety Management Team (SMT) and other executive forums for assigned products
- Created TFQs (targeted follow-up questionaries) for the AESIs of Nervous System SOC to submit to the clinical assessment of the AEs for medically confirmed source documents
- Support medical safety consultation activities in matters related to risk/benefit and proper product safety usage
- Conducting portfolio assessments, risk-management monitoring, assessment, and refinement of the plans Screening of local literatures for adverse drug reactions, adverse events with special interest or other relevant safety data on a weekly basis or according to journal publications.
ICSR Reviewer
Astellas
01.2020 - 09.2021
- Analyzed vendor performance indicators and safety/clinical data, while offering quality checks of important delivery documents
- Examined source documents to verify case accuracy to achieve the defined compliance standards
- Oversaw quality evaluation of ICSRs to verify data entry accuracy by checking against source documentation and the drug safety database for the assigned medicinal product
- Exhibited strong collaboration abilities to enhance consistency in processes, procedures, with quick and high-quality compliance with regulatory standards
- Managed to demonstrate competency with MS Windows, Excel, Word, and Outlook as well as the client Global Safety Database and Argus Safety
- Utilized strong oral and written communication abilities to ensure proper processing of AE cases and maintained continuous medical judgement within drug safety database
- Ensured successful completion of tasks and monitored vendors’ performance by utilizing strong knowledge of work procedures, Standard Operating Procedures (SOPs)
- Draft medical safety response for queries received from various Health Authorities with analysis of source data as per the query received
- Compared transcription and medical accuracy of adverse event source documents within the Safety Database screens by utilizing and implementing medical expertise
- Assisted in creation, review, and implementation of tools/documents in case processing, analyzing and resolving the discrepancies of SAEs
- Support implementation for new partnerships and maintenance of the PV agreements
- Evaluated the clinical information provided in ICSRs, and relevant factors in determination of expectedness of the products
- Assist Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy
- Assist in monthly quality evaluation of medical case review through ICSR review, feedback to Medical Review team, issue escalation and continuous process improvement
- Monitoring and evaluating the analyzing root causes issues and ensured site issue management by the metrics
- Identification and documenting the issues in monitoring the ICSR reporting quality compliance and correspondence
- Provided follow-up requests with health care professional on clinical perspective to ensure full picture of possible adverse events.
Pharmacovigilance Associate
Nexus Pharmaceuticals
04.2016 - 12.2019
- Spearheaded several operations to create inquiries using ARGUS interface and submit for clarification, resolution, and communication
- Conducted thorough investigation into USPI and company's primary data sheet to accurately reflect listedness/expectedness of adverse occurrences
- Prepared precise clinical case summaries, while ensuring to include all pertinent details in chronological sequence
- Analyzed source documentation and implementation of data management for adequacy and retrieved pertinent information for further use
- Searched duplicate cases and recorded correct patient, product, and migration of AE data within the Argus
- Implemented ARGUS tools for communication and follow-up requests, such as action items, contact logs, duplicate search, work lists
- Distributes notifications of ICSR to study team/Sponsor including case triage and submission requirements
- Participates in ICSR reconciliation between Clinical database and Safety database as required
- Performs intake, review, analysis, and data entry of ICSRs into tracking system, regulatory report, and/or Safety database
- Provided ICSR narratives by interpreting the reported event information, including medical conditions, laboratory results, and medical procedures by utilizing the MedDRA & WHO coding conventions
- Perform medical review of serious individual case safety reports, SUSARs by ensuring the migration of data by E2B
- Assessing, processing and entering key data around adverse event (AE) case types, review of narrative summary and provide case comments; provide medical inquiries for follow-up
- Responsible for determining MedDRA event coding for SAE reconciliation, AE reports for medical queries and data repository
- Maintains tracking tools for departmental key performance/quality indicator metrics
- Contribute to identification of standards, processes, controlled documents (including SOPs, Work Instructions, etc) aligning with established and developing regulatory requirements for ICSR medical assessment and management
- Review the Safety Management Plan (SMP), PV agreements, Safety Data Exchange Agreements (SDEA) with business partners globally to ensure compliance
- Reviewed source documents, literature assessment for AEs, ADRs, and medical review of the reported articles
- Requesting queries to safety responsible personnel for missing information
- Accountable for accurate data entry, quality review of individual case safety reports and writing case narratives as per regulatory format and timely delivery drug safety data with quality standards
- Performed coding of adverse reactions and drugs using MedDRA, writing case narratives/event description as per the regulatory format
- Processed SUSAR cases sources, including clinical trials, post-marketing, and literature-solicited instances of both serious adverse events and non-serious adverse events.
Education
Certifications - Regulatory Writing-Clinical Trials
University of Chicago
IL07.2023
Certification - Pharmaceutical Sciences
Online
NJ07.2015
M.D. - Medicine
NTR University of Health Sciences
Vijayawada, India10.2011
Skills
- Signal Detection & Validation
- Aggregate Reporting
- MedDRA & WHO Drug Dictionary
- Vendor management
- Quality compliance
- REMS assessment
- Individual Case Safety Reports
- AEs/SAEs Management
- Drug development
- SDEAs
- ICSR Processing & Management
- Argus Safety
- Narrative & Medical Writing
- Planning & Time Management
- Medical device regulations
- Regulatory Writing
- Health Risk Assessments
- Documentation And Reporting
- Regulatory Compliance
- Clinical judgment
- HIPAA Compliance
- Patient Management
Education Certification
- MD, NTR UNIVERSITY OF HEALTH SCIENCES, Vijayawada, Andhra Pradesh, 2011
- HIPAA Compliance Certification, 2011
- Advanced Drug Safety and Pharmacovigilance Certification, 2015
- Regulatory Writing certified from University of Chicago Illinois, 2023
- Clinical Research Certification, 2024
- PV Aggregate Reporting Certification, 2024
Timeline
Physician Medical Reviewer
Altria
01.2023 - Current
Pharmacovigilance Scientist (Signal Detection)
Pro Pharma Group
10.2021 - 12.2022
ICSR Reviewer
Astellas
01.2020 - 09.2021
Pharmacovigilance Associate
Nexus Pharmaceuticals
04.2016 - 12.2019
Certifications - Regulatory Writing-Clinical Trials
University of Chicago
Certification - Pharmaceutical Sciences
Online
M.D. - Medicine
NTR University of Health Sciences
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