Noelle Boisvert-Roach

About Noelle Boisvert-Roach

I am a senior Pharmacovigilance and Clinical Research professional with 13 years of experience supporting global clinical trials, drug safety operations, and regulatory reporting across a wide range of therapeutic areas, such as infectious disease, nephrology, neurology, hematology, hepatology, cardiovascular disease, gastroenterology, and oncology. My background includes end-to-end safety case processing, MedDRA/WHODrug coding, narrative writing, expedited reporting in both early phase trials and Post-marketing. I am passionate about building high-quality, inspection-ready safety systems and partnering with clinical, regulatory, and data-management teams to ensure patient safety and compliance. I have worked extensively in Oracle Argus, ArisG, Medidata Rave, Oracle InForm, and multiple EDCs. I thrive in environments where accuracy, timeliness, and collaboration matter.Known for my strong communication skills, cross-functional leadership, and ability to mentor and support teams, I enjoy improving processes, contributing to SOP development, and supporting audits and inspections. I am currently expanding my expertise with MedDRA certification (2025) and active involvement in DIA and RAPS.

Experience

1. Senior Clinical Drug Safety Specialist

   Inseption Group

   Oct 2023 — Present · Philadelphia, PA, US

   inSeption is a global full-service outsourcing company with deep experience managing complex programs in oncology, neurodegenerative disorders, rare disease, and other conditions, with a specialized focus on gene therapy and cell therapy.Core Responsibilities and Expertise:Comprehensive management and reporting of adverse events in Phase I and II clinical trials, including meticulous documentation, timely regulatory submissions, and adherence to global safety standards to ensure accurate early-stage safety assessments.• Case Management: Proactively manage case prioritization to ensure compliance with global regulatory reporting requirements. Process and assess serious adverse events (SAEs) from receipt to closure, including query generation, narrative creation, and AOSE analysis, using the Argus Safety Database.• Regulatory Compliance: Conduct assessments of seriousness, expectedness, causality, and reportability in alignment with global pharmacovigilance guidelines. Review and submit expedited reports to regulatory authorities, IRBs, and Ethics Committees.• Data Quality and Reconciliation: Perform duplicate checks, data entry, quality reviews, and reconciliations between clinical and safety databases, ensuring precise coding with MedDRA and WHODrug Global standards.• Collaboration and Leadership: Liaise with Business Development and Clinical Development teams to support sustainable client relationships. Provide onboarding, training, and functional support for drug safety personnel, fostering team growth and operational excellence.

Education

• Husson University

  Nursing

• University of Maine at Farmington

  Bachelor of Science (B.S.)

Skills

• Pharmacovigilance
• Drug Safety
• Pharmaceutical Industry
• Clinical Research
• Adverse Event Reporting
• CRO
• Medicine
• Clinical Trials
• Arisg
• Meddra
• Leadership
• Medical Terminology
• Report Writing
• Microsoft Office
• Microsoft Excel
• Trackwise
• Employee Training
• Management
• Client Relations
• Healthcare
• Peer Mentoring
• Insurance Verification
• Professional Writing
• Speech Therapy
• Customer Service
• Volunteering
• Trustee
• Standard Operating Procedure (Sop)
• Ich-Gcp
• Good Clinical Practice (Gcp)
• CRO Management
• Elementary Education
• Early Childhood Education
• Standardized Testing
• Middle School Education
• Special Education
• Child Development
• Case Narrative Writing
• Argus
• Inform