CVP is seeking a highly talented Pharmacovigilance SME to provide pharmacovigilance knowledge and guidance to contractor staff, ensuring compliance with industry standards. 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.
- Provide pharmacovigilance knowledge and guidance to contractor staff, ensuring compliance with industry standards
- Implement and optimize intake, case management, and reporting of Individual Case Safety Reports (ICSRS)
- Act as the liaison between contractor and government teams to ensure requirements are uniformly understood and agreed upon
- Experience in implementing and optimizing intake, case management and reporting of ICSRs for both premarket and post-market 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.
- 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 Harmonization 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 Labeling (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
- Experience in facilitating meetings, eliciting and documenting requirements, and performing user acceptance testing and training
Customer Value Partners, Inc. is a VEVRAA Federal Contractor and an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability. Customer Value Partners seeks to provide employment opportunities for protected veterans and individuals with disabilities.