Manager, Global Safety Compliance (Hybrid)

As the Manager, Global Safety Compliance at AbbVie, your main responsibilities will revolve around supporting the development and maintenance of a Quality Management System within the Pharmacovigilance and Patient Safety (PPS) organization. You'll manage audit processes, oversee compliance metrics, and ensure adherence to regulations during audits and inspections. Additionally, you will review reports of non-conformances and develop improvement plans, contributing to continuous enhancement in compliance practices.

Applicants for the Manager, Global Safety Compliance position at AbbVie should have a Bachelor’s degree in a relevant health science or quality-related field. A minimum of 4 years of clinical experience or 3 years in a pharmaceutical setting is also required. This role demands a keen understanding of pharmacovigilance processes and a passion for ensuring compliance excellence.

Yes, the Manager, Global Safety Compliance position at AbbVie offers a hybrid work schedule. This means that you will spend three days a week onsite at our Lake County Headquarters in North Chicago, IL, while the remaining days can be worked remotely, providing flexibility to maintain a healthy work-life balance.

AbbVie is committed to the professional development of its employees. In the Manager, Global Safety Compliance role, you’ll have opportunities to engage in new initiatives and propose enhancements to existing compliance processes. Moreover, AbbVie's supportive environment encourages continuous learning, making it easier to progress and expand your skills within the organization.

AbbVie prides itself on being an equal opportunity employer. For the Manager, Global Safety Compliance role, the company actively seeks to hire qualified individuals without discrimination based on race, color, religion, national origin, age, or other protected statuses. AbbVie values diversity and is dedicated to creating a welcoming work environment for all employees.

When answering this question, highlight your relevant clinical and pharmaceutical experience. Discuss specific projects or responsibilities that demonstrate your understanding of compliance and regulatory requirements in pharmacovigilance. Share examples of how you've successfully led audits or resolved complex compliance issues, showcasing both your technical knowledge and leadership skills.

Describe your methodical approach to audits and inspections, emphasizing the importance of preparation and documentation. Talk about your ability to coordinate audit activities, engage with stakeholders, and develop improvement plans based on findings. Providing concrete examples of successful audits you've led will showcase your qualifications.

Discuss the importance of various compliance metrics such as deviation rates, audit findings, and CAPA closure rates. Emphasize your understanding of how these metrics can indicate the overall health of the Quality Management System and help identify areas needing improvement, aligning perfectly with the objectives of the Manager, Global Safety Compliance role.

Certainly! Explain that the Corrective and Preventive Action (CAPA) process is designed to resolve identified non-conformances to ensure product safety and compliance. Discuss how you implement CAPAs based on audit findings, emphasizing the importance of thorough root cause analysis and the follow-up necessary to prevent recurrence.

Share how you routinely follow industry news, subscribe to relevant publications, and participate in webinars or conferences to stay informed of regulatory changes. Mention any professional networks you’re part of, showcasing your commitment to ongoing learning in the pharmacovigilance space.

Provide a specific scenario where you encountered a compliance challenge, detailing the nature of the issue. Highlight the steps you took to investigate, the analysis performed, and how you collaborated with colleagues to resolve the matter, showcasing your problem-solving skills and teamwork.

Discuss your familiarity with compliance tracking tools, such as database management systems or specialized software for safety reporting. Talk about how you utilize these tools for effective metric tracking and reporting to ensure transparency and accountability within your team.

Emphasize the importance of maintaining professionalism and diplomacy during audits. Discuss techniques you use to diffuse tensions, such as active listening and open communication. Sharing an example of a past experience where you resolved a conflict can demonstrate your conflict resolution skills.

Discuss how proactive risk management involves identifying potential safety risks before they manifest into real problems. Explain the importance of a well-defined risk assessment process and how you have successfully implemented such practices in previous roles to minimize safety-related incidents.

Share insights on the evolution of regulatory landscapes, increasing demands for transparency, and the pressure to ensure data integrity in pharmacovigilance. Discuss how these challenges require compliance professionals to adapt continuously and be proactive in enhancing compliance practices.