ELSA GRACE JOHN

● Supported site feasibility assessments, site training plan, recruitment, and enhancement of site management.

● Reported Adverse Events and/or other reportable event to regulatory authorities (UK-MHRA, Belgium, Netherlands, and US-FDA) within timelines.

● Managed the integrity and accuracy of scientific and medical data communicated both internally and externally for promotional and non-promotional purposes.

● Review and oversee the safety strategy for class ll wearable medical devices and Software including AI- enabled algorithms.

● Authored Safety SOPs and Safety Management plan for the team.

● Contributed to the development and amending of clinical documents such as protocols, informed consent forms, project plans, adverse event forms, study reports, and annual reports.

● Ensured the safety email was set up and maintained appropriately throughout the trial.

● Participated in the review and approval of monitoring visit reports of AE.

● Understood the need for and importance of being inspection-ready and diligently followed SOPs.

● Participated in EDC build of clinical trial study's safety and adjudication platform (Axiom and Imedi Data Rave).

● Participated in clinical database design User Acceptance Testing (UAT).

● Reviewed clinical monitoring reports to ensure timely completion and identification of issues.

• Supported site feasibility assessments, site training plan, recruitment, and enhancement of site management.
• Reported Adverse Events and/or other reportable event to regulatory authorities (UK-MHRA, Belgium, Netherlands, and US-FDA) within timelines.
• Managed the integrity and accuracy of scientific and medical data communicated both internally and externally for promotional and non-promotional purposes.
• Review and oversee the safety strategy for class ll wearable medical devices and Software including AI-enabled algorithms.
• Authored Safety SOPs and Safety Management plan for the team.
• Contributed to the development and amending of clinical documents such as protocols, informed consent forms, project plans, adverse event forms, study reports, and annual reports.
• Ensured the safety email was set up and maintained appropriately throughout the trial.
• Participated in the review and approval of monitoring visit reports of AE.
• Understood the need for and importance of being inspection-ready and diligently followed SOPs.
• Participated in EDC build of clinical trial study’s safety and adjudication platform (Axiom and Imedi Data Rave).
• Participated in clinical database design User Acceptance Testing (UAT).
• Reviewed clinical monitoring reports to ensure timely completion and identification of issues.

Trial Name: I SPY COVID Trials

● Provided baseline resolution of SAE and AESI within EDC and Argus safety database.

● Oversaw vendor activities and escalated issues for resolution.

● Identified and assisted in the development, revision, and review of CAPA, WI, and SOP for Covid Clinical trial study.

● Provided strategic and scientific support to the clinical site team to ensure the successful execution of clinical trial monitoring and reporting.

● Assisted in training site CRA.

● Solved problems with a huddle in slack and communicate perceptions and understandings on Google workspace using Miro board for the team's visual coordination and Fishbone for causal analysis of a concern.

Managed study-related documents such as case report forms (eCRF), monitoring plans, informed consent, recruitment materials, and other study-related tools in EDC.

● Reviewed Dossier for a pragmatic clinical trial and acted as the sponsor's liaison to resolve site CRA-related issues quickly and effectively.

● Uploaded TMF to Veeva vault.

● Managed external vendors and CROs to ensure deliverables were completed on time and were consistent with the scope of work and GCP.

● Supported preparation for regulatory inspections and audits with an evaluation of current processes and assessed alignment with regulatory expectations, and Good Clinical Practice guidelines.

● Reconciled events for insured patients, correspondingly complying with HIPAA and other applicable regulatory guidelines.

● Coordinated with the trial site to determine if the reported complaint was associated with a malfunction, serious injury, or death and whether the complaint documentation was completed and accurate.

● Created WI for CRA for the Pfizer covid study to enter site visits, AE reports and study related vaccination details.

● Handled study-related documents such as case report forms (eCRF), monitoring plans, informed consents, recruitment materials, and upload TMF to Veeva Vault.

● Assisted in AE/SAE ICSR reconciliation and ensured reporting consistency in safety and EDC database.

● Led safety review meetings for the evaluation of clinical data to support signal detection.

● Authored safety management plan for the Pfizer covid study.

● Assisted in the EDC study build for Pfizer covid study as per sponsor protocol requirements.

● Liaised between CRA and sponsor during sponsor site audits.

● SME at the time of FDA audit for an IND project and NIH funded medical device study.

● Performed quality-related activity for Field Alert Reports (FARs) assigned for FDA reporting.

● Served as a safety point of contact to other departments and FMCRTG, LLC licensing partners.

● Liable for overseeing all aspects of adverse event case processing and reporting to FDA for the assigned investigational and marketed products delegating tasks and responsibilities to the appropriate personnel.

● Acted as the liaison to external contract safety providers and company personnel to comply with safety reporting in conjunction with the GCP and ICH instructions.

● Collaborated with data management, clinical operations, regulatory affairs, CRA, quality, and medical affairs teams for good quality safety reporting to FDA.

● Reviewed and coded all medical terminologies in MedDRA dictionary to project-specific coding conventions, package insert, investigator brochure, and company core data sheet.

● Ensured overall compliance with ICH, EMEA, and FDA guidelines.

● Confirmed post-marketing adverse event reports were received, tracked, evaluated, processed/translated, and distributed in an efficient and timely manner and in compliance with FDA GCP regulations.

● Participated in FDA audits and inspections as a subject matter expert.

● Resolved vendor questions and escalates issues to the in-house PV Science Manager.

Clients: Pfizer, Immunogen

● Prepared and tracked clinical event dossiers for submission to Clinical End Point Committee (CEC).

● Tracked adverse events reported in EDC (electronic data capture) system for dossier updates and initialized adjudication alerts.

● Communicated with investigative sites and CRAs to gather documents to support the adjudication process for submission to medical monitors.

● Triaged ICSR into safety database and tracking systems such as Argus and VCAS (virtual clinical adjudication system).

● Followed up with CRA for additional information as per FDA and GCP standards.

● Created and maintained project-specific working files, SOP, and case report files.

● Ensured quality of electronic documentation such as in 21 CFR part 11.

● Collected source documents for adjudicating such as data entry, query sites, document translations, and redact subject identifiers.

● Submitted the completed dossier for adjudication to the medical monitor by securing and obeying 45 CFR part

46 of the subject's source documents.

● Reviewed protocols, investigator brochures, and Case Report Forms (eCRF) to ensure FDA and GCP principles in safety reporting.

Clients: Pfizer, Biogen, Daiichi Sankyo (legal team), Regeneron

● Performed medical coding of reported adverse events and changed auto-coded terms to correctly coded terms.

● Extracted medical facts from plaintiff fact sheets, pharmacy records, and medical records to code the events and processing of legal cases.

● Triaged current incoming cases to meet timelines by performing quality reviews of spontaneous cases.

● Provided training and mentored the new hires on legal case processing.

● Conducted clinical reviews of all domestic and foreign adverse event reports for client-specific marketed products.

● Evaluated adverse events reports for signal detection and risk management and determined if new risks associated with a particular drug or if known risks with a drug were changed.

● Submitted periodically aggregate safety reports to the sponsor for an overview of the safety profile of the project-specific drug,

● Completed end-to-end process of ICSR.

Clients: Johnson & Johnson

● Performed medical coding using MedDRA and WHO drug/CDD for ICSR.

● Drafted individual case summary reports, wrote concise case-specific narratives per company and product conventions, and closed and deleted cases.

● Received and tracked information regarding potential adverse events submitted by reporters, consumers, healthcare professionals, co-manufacturers, call centers, medical information centers, and other company representatives accurately within defined reporting timelines.

● Assisted with preparation, and review of regulatory reports CAPA (corrective and preventative actions) by evaluating the data and identifying the risks.

● Trained in literature surveys, reviewing, assessing, and decision making for case reportability by looking for positive attribution in the literature article.

● Assisted in writing SOPs, work instructions, and templates for efficient and effective processing of ICSRs and aggregate reports.

● Audited preparation and safety data checks.

Master of Science in Medical Microbiology | Long Island University, New York | 2010

Master of Science in Biotechnology | Punjab Technical University, India | 2007

Bachelor of Science in Microbiology | Kannur University, India | 2003