Manager, Office of Safety Operations

Summary

Join AbbVie's Safety Operations organization as a Manager, Office of Safety Operations, and play a vital role in ensuring global regulatory compliance for adverse event reporting. You will design and implement efficient ICSR pharmacovigilance processes, lead process improvements, and collaborate with cross-functional teams. The role involves managing investigations, supporting audits and inspections, and optimizing global ICSR operations. You will also develop and manage a team, providing coaching and mentorship. This position offers the flexibility of remote work within the US. AbbVie is committed to improving patient lives through high-quality adverse event management and industry-leading ICSR operations.

Requirements

• Bachelor’s Degree or equivalent in related science field
• +5 years pharmaceutical industry experience; including a minimum of 3 years in pharmacovigilance
• Global experience
• Core knowledge of global Pharmacovigilance regulations (ICH, EMA, FDA) and the affiliate environment, with a firm understanding of related quality assurance systems
• Experienced in health authority inspections and/or internal or third-party audits
• Experienced in developing training & quality documents (SOP / Guidelines / CAPAs)
• Skilled in data interpretation; experienced with using excel
• Proficient in case processing processes, procedures, conventions
• Able to influence across stakeholders and manage within a cross-functional matrix; seen as a collaborative partner within the organization
• Able to identify, assess, and effectively manage business and compliance risks

Responsibilities

• 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 with relevant AbbVie stakeholders, including PPS, Commercial, GMA, RDQA, and Affiliates to establish and maintain harmonized ICSR processes
• Leads internal audits and external regulatory inspection activities; supports functional corrective and preventive action investigations
• Supports PPS’ understanding of the changing regulatory environment as it impacts ICSR management, process, technology, and people
• Leverages global data and cross-functional insights to optimize global ICSR operations including design of effective training approaches
• Manages process improvement initiatives with effective change management and rapid solutioning of unanticipated issues
• Manages identification, prioritization, and timely resolution of potentially impactful issues, including clear communication and follow-up across stakeholders through resolution, prevention, and trending
• Responsible as a senior member of the Office of Safety operations team for driving compliance and process business excellence for all ICSR PV activities
• Presents results to senior AbbVie stakeholders. May participate in governance meetings, and maintains strong working relationship with colleagues in PPS, RDQA, and Affiliate PV & Quality organizations
• Develops and manages a team of AbbVie staff to execute the above responsibilities, including coaching/mentoring for staff performance and development (up to 5 people)

Preferred Qualifications

• Experience in leading cross-functional teams
• Established influencing skills

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs