AbbVie

Director, OneHUB Product Safety Surveillance OUS

AbbVie • $150K — $180K *
North Chicago, IL 60064In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in nursing or a scientific field preferred, advanced degree desirable.
  • 8+ years in clinical development, pharmacovigilance, or related experience, with 4+ years in management.
  • Extensive knowledge of clinical safety/product quality complaint reporting and intake processes.
  • Strong understanding of global/OUS regulatory frameworks, particularly EU regulations.
  • Fluency in application of SOPs, regulations, and vendor management.

Responsibilities

  • Lead OUS AE and PQC intake operations across teams and vendors in diverse markets.
  • Oversee end-to-end quality complaint intake, ensuring proper documentation and logistics.
  • Ensure accurate and timely routing of AE and PQC cases in compliance with regulations.
  • Manage vendor performance and monitor service quality against SLAs and quality metrics.
  • Forecast workload and staffing needs aligned with intake volumes and budget.
  • Ensure compliance with pharmacovigilance, quality procedures, and privacy standards.
  • Support audit readiness and execute corrective actions for operational findings.
  • Serve as contact for Global Safety, translating regulatory updates into operational changes.
  • Drive continuous improvement in AE and PQC intake processes, focusing on efficiency.

Benefits

  • Paid time off (vacation, holidays, sick)
  • Medical, dental, and vision insurance
  • 401(k) plan participation
  • Eligibility for long-term incentive programs
Full Job Description
Job Description

Purpose

The Director, OneHUB Product Safety Surveillance OUS provides leadership and oversight for the teams responsible for adverse event (AE) and product quality complaint (PQC) intake across markets outside the United States. This spans both in-house teams and third-party vendor partners delivering AE intake and OUS quality complaint intake across pharma/combination products and medical devices. The role manages operational delivery and vendor performance, ensures timely and accurate intake of safety and quality information across OUS markets and languages, and maintains compliance with applicable regional pharmacovigilance and quality regulations, GxP documentation standards, and AbbVie policies - operating within process standards and SOPs owned by the relevant business functions.

Responsibilities
  • Lead operations for OUS adverse event (AE) and product quality complaint (PQC) intake, covering both in-house teams and third-party vendors across OUS markets, time zones, and languages.
  • Oversee OUS quality complaint intake end-to-end across product types, including multilingual complaint intake and classification, complaint documentation, and coordination of sample-return logistics where applicable.
  • Ensure AE and PQC cases are captured, documented, and routed accurately and on time, in line with regional regulatory reporting requirements.
  • Manage vendor performance against defined SLAs and quality metrics, monitor non-technical service quality (including call quality and response standards), and keep internal business partners informed of outcomes and issues.
  • Own workload forecasting and staffing planning across OUS markets, ensuring stays aligned with intake volumes and budget.
  • Ensure teams follow applicable pharmacovigilance and quality procedures, GxP documentation standards, and local privacy requirements, operating within SOPs and process standards owned by the relevant business functions.
  • Lead audit readiness and support internal and external audits and health authority inspections; own execution of non-technical operational corrective actions (CAPAs) and ensure findings are remediated on time.
  • Serve as the operational point of contact for Global Safety and Post-Market Quality Assurance, translating regulatory and policy updates into operational adjustments to intake workflows, in coordination with the relevant business functions.
  • Drive continuous improvement across OUS AE and PQC intake processes, focused on non-technical error reduction, documentation quality, and workflow efficiency.
  • Identify, escalate, and mitigate operational risks that could affect patient safety or regulatory compliance.


Qualifications

Education
  • Bachelor's degree in nursing or a scientific field preferred; advanced degree desirable.

Experience
  • 8+ years of clinical development, pharmacovigilance, or directly related experience, including 4 or more years of direct management experience.
  • Demonstrated experience operating across OUS / international markets, with cross-discipline exposure to clinical safety and/or product quality complaint reporting.

Functional & Regulatory Knowledge
  • Extensive knowledge of clinical safety and/or product quality complaint reporting and intake processes.
  • Strong understanding of the global and OUS operating environment from both operational and regulatory/GVP/GCP perspectives, including EU and other regional health authority frameworks.
  • Fluency in standard business procedures (SOPs, global/regional regulations, ethics and compliance, outsourcing/vendor management, PV/PQC) and their application to the business.

Leadership & Competencies
  • Proven organizational, project management, and leadership skills, with the ability to lead the OneHUB OUS Product Safety Surveillance team within a global matrix environment.
  • Demonstrated ability to build effective working relationships across functions and geographies, applying industry best practices that drive process improvement across OUS markets.

Key Stakeholders

OneHUB leadership team; International Strategy & Safety Operations function leadership team; Post Market Quality Assurance function leadership team; Global Patient Safety / Pharmacovigilance organization (including the EU QPPV office); Regulatory Affairs and Commercial Quality functions; OUS affiliates and regional safety and quality leads; Outsourced third-party vendor partners

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

Join Our Team

Search open positions that match your skills and interests. We are looking for passionate, curious, and innovative team players who are ready to make a difference.

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Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ
ABBV
* Ladders Estimates

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