Job Title

Manager, Office of Safety Operations (Remote), MaidenheadClient: AbbVie Location: Maidenhead, UK (Remote options available) Job Category: Other EU work permit required: Yes Job Reference: 2def6c06c807 Job Views: 3 Posted: 23.05.2025 Expiry Date: 07.07.2025 Job DescriptionThis role supports the Safety Operations organization in improving patient lives through high-quality adverse event management and leading ICSR operations, standards, and technology at AbbVie. The Manager, Office of Safety Operations, is part of the ICSR Compliance department within Safety Operations. The position involves monitoring compliance with global regulatory reporting of ICSRs, managing investigations to address deviations, and ensuring alignment with safety data exchange requirements. The role also supports audits and inspections by providing documentation, data analysis, and expertise. ResponsibilitiesDesign and implement compliant ICSR pharmacovigilance processes, technologies, and training. Lead improvements in global case management processes, technology, and training. Implement new legislation into quality systems and training. Collaborate across functions to harmonize ICSR processes with stakeholders such as PPS, Commercial, GMA, RDQA, and Affiliates. Lead audits and inspections; support CAPA investigations. Stay informed on regulatory changes impacting ICSR management. Use data and insights to optimize ICSR operations and training. Manage process improvements and change management initiatives. Identify and resolve impactful issues, communicating effectively across stakeholders. Drive compliance and process excellence as a senior team member. Present results to senior stakeholders and participate in governance meetings. Develop and manage a team (up to 5 staff), including coaching and mentoring. QualificationsBachelor’s Degree or equivalent in a related science field. Experience in the pharmaceutical industry, including pharmacovigilance. Knowledge of global pharmacovigilance regulations (ICH, EMA, FDA). Experience with health authority inspections and audits. Proficiency in developing training and quality documents. Skilled in data interpretation and Excel. Proficient in case processing procedures. Strong influencing and stakeholder management skills. Experience in leading cross-functional teams preferred. Additional InformationAbbVie is an equal opportunity employer committed to integrity, innovation, and community service. For more information, visithere . Applicants seeking accommodations can learn more atthis link .#J-18808-Ljbffr