Manager, Office of Safety Operations - Remote

Overview

This position supports the Safety Operations organization to achieve its mission of improving patient lives by delivering high quality, and timely adverse event management and through driving industry leading ICSR operations, ICSR standards and technology at AbbVie.

In Short

• Designs and implements compliant and efficient ICSR pharmacovigilance processes, technologies & training
• Leads improvement of Abbvie’s global clinical and post-marketing case management processes, technology & training
• Implements new ICSR pharmacovigilance legislation into quality systems, metrics, technical requirements & training
• Leads effective cross-functional collaboration with an emphasis on building business relationships
• Supports internal audits and external regulatory inspection activities
• Manages process improvement initiatives with effective change management
• Responsible for driving compliance and process business excellence for all ICSR PV activities
• Presents results to senior AbbVie stakeholders
• Develops and manages a team of AbbVie staff

Requirements

• Bachelor’s Degree or equivalent in related science field
• +5 years pharmaceutical industry experience; including a minimum of 3 years in pharmacovigilance
• Core knowledge of global Pharmacovigilance regulations (ICH, EMA, FDA)
• Experienced in health authority inspections and/or internal or third-party audits
• Skilled in data interpretation; experienced with using excel
• 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

Benefits

• Comprehensive package of benefits including paid time off
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Eligible to participate in short-term and long-term incentive programs