Manager, Office of Safety Operations (Remote)

TN United Kingdom; Maidenhead; Remote; GBP 50,000 - 80,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Manager for the Office of Safety Operations. This remote role involves overseeing compliance with regulatory reporting, managing investigations, and leading process improvements in pharmacovigilance. The ideal candidate will have a strong background in the pharmaceutical sector, excellent stakeholder management skills, and experience in leading cross-functional teams. Join us to make a significant impact on patient safety and operational excellence.

Qualifications

• Experience in the pharmaceutical industry, including pharmacovigilance.
• Knowledge of global pharmacovigilance regulations (ICH, EMA, FDA).
• Experience with health authority inspections and audits.

Responsibilities

• Design and implement compliant ICSR pharmacovigilance processes.
• Lead improvements in global case management processes.
• Manage audits and inspections, providing documentation and data analysis.

Skills

Data interpretation

Stakeholder management

Process improvement

Training development

Influencing skills

Education

Bachelor’s Degree in a related science field

Tools

Excel

Job description

Manager, Office of Safety Operations (Remote), Maidenhead

Client: 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 Description

This 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.

Responsibilities

• Design 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.

Qualifications

• Bachelor’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 Information

AbbVie is an equal opportunity employer committed to integrity, innovation, and community service. For more information, visit here. Applicants seeking accommodations can learn more at this link.