Pharmavise Corporation is the first Continuous Compliance Organization (CCO) dedicated to maintaining the highest standards of quality and regulatory compliance in the life sciences industry. Our esteemed client base includes Fortune 500 companies in pharmaceuticals, medical devices, and biotechnology. We offer bespoke solutions tailored to meet the specific compliance needs of our clients, supporting them from development through commercialization and ensuring they exceed their compliance goals while enhancing patient health and safety.
FDA Compliance Consulting • Project Management • Auditing • External Supply Operations • Quality Systems Management
October 3, 2024
Pharmavise Corporation is the first Continuous Compliance Organization (CCO) dedicated to maintaining the highest standards of quality and regulatory compliance in the life sciences industry. Our esteemed client base includes Fortune 500 companies in pharmaceuticals, medical devices, and biotechnology. We offer bespoke solutions tailored to meet the specific compliance needs of our clients, supporting them from development through commercialization and ensuring they exceed their compliance goals while enhancing patient health and safety.
FDA Compliance Consulting • Project Management • Auditing • External Supply Operations • Quality Systems Management
• Data engineering expertise with demonstrated database and clinical domain knowledge to manage data taxonomies in support of SoA and eCOA designs and related considerations (e.g. Decentralized Clinical Trials, Cost, Patient Burden, Investigator Site Burden, etc) • Manage taxonomy governance cross-functionally and ensure taxonomy data is accurate and complete in partnership with cross functional teams. • Act as liaison between application development and business teams. • Analytical ability to use complex software systems while synthesizing data and information. • Responsible for updating Patient Burden and Investigator Site Burden framework and other metrics in-app calculations as required by business. • Expert in key data sources (e.g. TrialTrove, DQS, ct.gov) and clinical development. • Delivers data strategy for algorithms and metric calculations across the app in line with business requirements. • Responsible for troubleshooting and managing issues related to taxonomy and in-app data analytics to resolve issues and minimize disruption to end users.
• Bachelor’s Degree in a scientific or health-related field • Minimum 5 years’ experience in the pharmaceutical industry, drug development, and/or related fields • Proficiency with data/text mining & querying tools; analytic and programming tools (Python, SQL, Node.JS, Regular expression & NLP, GraphQL, etc) • Experience with Agile Development, Jira, GitHub, and AWS data technologies • Taxonomy/Ontology management experience
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