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Capgemini Government Solutions (CGGS) is searching for a Pharmacovigilance Expert for future opportunities on our Civil team in the DC area.
• Experience in implementing and optimizing intake, case management and reporting of Individual Case Safety Reports (ICSRs) for both premarket and postmarket setting and product complaint reports, as well as, business analysis experience, specifically, soliciting customer requirements, tracking, documenting, and reporting on planning, user acceptance testing, and training. Working with the Systems and Business Analysts, will be one of the key personnel acting as the liaison between contractor and government teams to ensure requirements are uniformly understood and agreed upon.
• Understanding of different ICSRs intake channels like fax, email, paper including electronic submission via gateway and is able to automate data intake and processing.
• Well versed in International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2B (E2B is the international standard for transmitting medicine adverse event reports) data standards and Implementation Guide with experience in converting ICH E2B (R2) message to ICH R2B (R3) keeping in mind the backward and forward compatibility and data migration issues.
• Understanding of auto-coding key data points using dictionaries for product, manufacturer and MedDRA.
• Knowledge of Structured Product Labelling (SPL) product identifiers and characteristics and International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP)
• Experience with the implementation of Commercial off-the-shelf (COTS) Pharmacovigilance software tools
• Provide pharmacovigilance knowledge and guidance to contractor staff, ensuring compliance with industry standards.
• Experience in facilitating meetings, eliciting and documenting requirements, and performing user acceptance testing and training
•3-6 years of relevant experience
• Case Management
• COTS Pharmacovigilance Implementation
• Business Analysis
• Requirements Elicitation, Facilitation, Documentation
• End User Training
• ICSR Intake Channels
• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2B Data Standards and Implementation
• Conversion of ICH E2B (R2) messages to ICH E2B (R3)
• Structured Product Labelling (SPL)
• Pegasystems, ideally Pega 7 or Pega PV
Capgemini, one of the world's foremost providers of consulting, technology, and outsourcing services, enables its clients to transform and perform through technologies.
Capgemini Government Solutions, LLC (Capgemini GS) is a subsidiary of Capgemini focused on providing high quality Capgemini services to the U.S. Federal Government.
Capgemini GS provides equal employment opportunities (EEO) to all employees and applicants for employment. In addition to federal law requirements, Capgemini GS complies with applicable state and local laws governing nondiscrimination in employment.
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