Records Management

Company: Cortech
Location: Kalamazoo
Posted on: June 26, 2022

Job Description:

Work Days & Hours : Monday-Friday, 8AM-5PM ACTUAL JOB TITLE: Pharmacovigilance Reporting/Metrics CoordinatorRemote PositionJob description summary:This position requires an understanding of pharmacovigilance practices with the responsibilities of applying this knowledge to assure regulatory compliance. This position contributes to regulatory activities focused on maintaining the in-line portfolio of company animal health products. This position requires the ability to organize and compile the required information and documents for regulatory submissions, understanding of regulatory requirements and the ability to apply knowledge of regulatory requirements. This position requires working in a team environment as well as autonomously to meet the daily job requirements. This position may contribute to special project work as assigned.Essential Duties and Responsibilities:1.Prepares and submits reports via approved databases, such as E-Submitter or PV Works.2.Communicates effectively (written and oral) and collaborates with other functional areas.3.Submits anti-microbial reports to the FDA for company pharmaceutical products through E-Submitter or other approved databases.4.Compiles and organizes reporting metric data for review.5.Contributes to special project work as assigned.Requirements:1. Bachelor's degree in biology, animal science, pharmacy, business or other related science.2. A minimum of 1 year of experience in the regulatory field.3. Experience in PV Works, Microsoft Office Suite (specifically Excel, experience with sorting, grouping, creating tables, pivoting and creating macros) preferred.

Keywords: Cortech, Kalamazoo , Records Management, Executive , Kalamazoo, Michigan