Jayawanth M Hatapaki

Ensured clinical data management aligned with regulatory standards

• Clinical Data Management activities for Phase I-IV clinical trials, ensuring data quality, integrity, and regulatory compliance.
• Preparation and review of Data Management Plan (DMP).
• eCRF Design and eCRF Annotation development based on client specific protocol including maintenance of Edit Check Specifications.
• EDC database build review, testing, and User Acceptance Testing (UAT).
• Managed EDC database Go-Live implementation activities to facilitate timely study start-up.
• Perform Medical Coding of Adverse Events, Medical History, and Concomitant Medications using MedDRA and WHO Drug Dictionary (WHO-DD).
• Up versioning of medical coding dictionaries on routine basis, ensure impact analysis on every up versioning.
• Performed comprehensive clinical data review and data cleaning activities.
• Generated, tracked, and resolved queries to uphold data quality standards.
• Support external data reconciliation (laboratory-Lab connect, lims, vendor, and third-party data).
• SAE Reconciliation between clinical and safety databases.
• Involved in Execution of Database Freeze, Database Lock, and Database Unlock procedures.
• Support for regulatory-compliant data management throughout the clinical trial lifecycle.
• Contributed to multiple clinical trial studies from start-up to conduct and close-out, ensuring adherence to regulatory compliance.
• Conducted Computer System Validation (CSV) for EDC, eTMF, and Safety Database applications, including system implementation, testing, and API integration validation to support compliant and efficient clinical trial data management.
• Support studies across CAR-T Cell Therapy (B-ALL, B-NHL, Multiple Myeloma, TNBC), Oncology, Solid Tumors, Vaccine Studies, and other therapeutic areas.

Managed pharmacovigilance operations for clinical trials

• Lead Pharmacovigilance operations, managing case processors, medical reviewers, and sponsor reviewers to ensure regulatory compliance.
• Function as Workflow Manager for safety databases, overseeing end-to-end case processing from case intake through case lock and regulatory submission.
• Manage Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources in accordance with global regulatory requirements.
• Perform case triage, medical review, narrative review, causality assessment support, and submission tracking.
• Monitor safety dashboards and case workflows to ensure compliance with reporting timelines.
• Coordinate Data Safety Monitoring Board (DSMB) activities, including safety listings and periodic safety reviews.
• Manage safety-related queries and communications with investigators, medical monitors, CRAs, CRCs, project managers, sponsors, and study sites.
• Prepare, review, and coordinate submission of DSURs, PSURs, and PBRERs.
• Conduct safety signal detection, trend analysis, and escalation of potential safety concerns.
• Act as SME during internal audits, sponsor audits, and regulatory inspections, including USFDA inspections.
• Review and manage Safety Data Exchange Agreements (SDEAs) and related compliance documentation.
• Perform medical review of clinical databases and ensure consistency between clinical and safety data.
• Develop SOPs, work instructions, and training materials for PV and clinical trial personnel.
• Maintain AE/SAE tracking systems and ensure accurate safety documentation and reconciliation.
• Support pharmacovigilance activities across Oncology, CAR-T Therapy, COVID-19, Congestive Heart Failure, Candidiasis, Hepatitis Vaccine, and other therapeutic areas.

• Oversaw complete case processing from initiation to completion. from book-in, data entry, adverse event pulling, coding of all events (by MedDRA 20.1) and drugs (by CPD or WHO DD), and narrative writing for medical review.
• Spearheading efforts across verifying overall consistency of cases, assessment of solicited non- serious and serious Oncology cases in Global safety data base Argus (version: 7.1).
• Coordinating with different functional team members, e.g. team leaders, and other health care professionals and QCs for completion of various cases with accurate consistency and proper validation.
• Solving the validation warning before routing to workflow.
• Work in accordance with business requirement of client.
• Successfully contributed knowledge and expertise to or lead assigned deliverables in the field of Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
• Handled various operational tasks to support team efficiency.: Manage Internal Operations.
• Ensure that the SDL is informed on operational issues (Metric performance, attrition).
• Tracked team adherence to defined service metrics (SLA): accuracy, timelines and productivity on a daily basis.
• Delivered constructive feedback to enhance performance and processes. to improve performance of process / individuals where required
• Effectively coach or counsel team on managing the process.
• Demonstrate Good Leadership skills with ability to communicate effectively.
• Develop and implement a continuous improvement program to increase efficiency and quality.

• Received information on adverse events from US and ROW countries, perform initial checks, search database to prevent duplicate entries in ARISg 7.4 (Delta) safety database, create case file and initialize received drug safety reports via mail or via IRT (AgXchange 7.4.0.6) tool and importing the same to Arisg database.
• Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timeliness and quality.
• Evaluate and finish processing of expeditable and non-expeditable AE reports, including review for completeness and accuracy.
• Use medical dictionaries and business guidance to code medical history, drugs (concomitants, past and suspects with devices) and adverse event terms. Prepare narratives summarizing the essential details of the case.
• Identify clinically relevant information missing from case report and facilitate its collection (in consultation with medical staff as required), preparing follow-up request as needed.
• Assist with related administrative and procedural activities as required or requested.
• Query management: Cases with query from data entry level to Medical approval.
• Assist in the training of other Safety Processing Experts as necessary.
• Worked for following markets: USA and ROW (rest of world).
• Receiving and Sending documents and CIOMS to Licensee partner and Vendor.
• Mail communication with Clients and sending of daily workflow status reports.
• Alert manager to potential safety signals based on incoming case reports.
• On daily basis and weekly basis reaching of 100 percent targets, giving a good quality of the case and reaching all SLA’s with meeting the KPI’s.
• Therapeutic areas exposed: Neuro degenerative drugs, diabetes, cardiac drugs, fertility drugs, growth
• hormone drug, thyroid disorder drugs, consumer health care products, anti-coagulants, anti-allergic and steroidal.
• Activity Performed: Data entry, Triage and Quality reviewer.
• As a Case Processor:
• ICSR case processing with different types of cases: Spontaneous Cases (serious and non-serious), Post marketing surveillance (solicited) cases, Legal (Lawsuit) cases, Clinical trial cases, License/Business partner cases, HA cases, Pregnancy cases (serious and non-serious), Fertility product cases, CHC (consumer health care) cases, ICH E2B I bond cases (R2) and ICH E2B EVW (R3) cases and Oncology cases.
• Assigned with the responsibility of entire case processing from Triage, data entry, all adverse event pulling, coding of all events (by MedDRA 20.1) and drugs (by CPD or WHO DD), narrative writing to medical review.
• Spearheading efforts across verifying overall consistency of cases, assessment of solicited or spontaneous non-serious cases in Global safety data base Arisg (7.4 Delta) and a importing tool IRT (AgXchange 7.4.0.6).
• Coordinating with different functional team members, e.g. team leaders, and other health care professionals and QC’S for completion of various cases with accurate consistency and proper validation.
• Solving the validation warning before routing to further workflows.
• Work in accordance of business requirement of client.
• Successfully contributed knowledge and expertise to or lead assigned deliverables in the field of Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.