Manager, Office of Safety Operations (Remote)

Bachelor's Degree or equivalent in related science field +5 years pharmaceutical industry experience Minimum of 3 years in pharmacovigilance Global experience Core knowledge of global Pharmacovigilance regulations (ICH, EMA, FDA) Understanding of related quality assurance systems Experienced in health authority inspections and/or internal or third-party audits Experienced in developing training & quality documents (SOP / Guidelines / CAPAs) Skilled in data interpretation Experienced with using excel Proficient in case processing processes, procedures, conventions Able to influence across stakeholders and manage within a cross-functional matrix Able to identify, assess, and effectively manage business and compliance risks Experience in leading cross-functional teams preferred Established influencing skills

Designs and implements ICSR pharmacovigilance processes, technologies & training Leads improvement of global case management processes, technology & training Implements new ICSR pharmacovigilance legislation into quality systems Leads cross-functional collaboration with stakeholders Leads internal audits and external regulatory inspection activities Supports understanding of the changing regulatory environment for ICSR management Leverages global data to optimize global ICSR operations Manages process improvement initiatives and change management Manages identification, prioritization, and resolution of issues Drives compliance and process business excellence for ICSR PV activities Presents results to senior stakeholders Develops and manages a team of up to 5 AbbVie staff