Manager, Office of Safety Operations

Purpose: 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.

Core Job Responsibilities include:
• 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) 

Qualifications:

•  Bachelor’s Degree or equivalent in related science field.
• +5 years pharmaceutical industry experience; including a minimum of 3 years in pharmacovigilance
• Global experience preferred
• Demonstrated experience in direct line management preferred
• 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
• Experience in leading cross-functional teams preferred
• Established influencing skills