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

• Located in the UK - can be home or office based in Maidenhead.
• Responsible for monitoring and ensuring compliance with global regulatory reporting of ICSRs.
• Manage investigations to address compliance deviations and drive continuous improvement.
• Support internal and external audits and regulatory inspections.
• Design and implement compliant ICSR pharmacovigilance processes and technologies.
• Lead cross-functional collaboration with relevant AbbVie stakeholders.
• Manage process improvement initiatives with effective change management.
• Develop and manage a team of AbbVie staff.
• Present results to senior AbbVie stakeholders.
• Drive compliance and process business excellence for all ICSR PV activities.

Requirements

• Bachelor’s Degree or equivalent in related science field.
• Experience within the pharmaceutical industry, including pharmacovigilance.
• Core knowledge of global Pharmacovigilance regulations (ICH, EMA, FDA).
• Experienced in health authority inspections and audits.
• Skilled in data interpretation and 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

• Equal opportunity employer committed to integrity and innovation.
• Opportunities for professional development.
• Dynamic work environment.
• Supportive team culture.
• Health and wellness programs.