Manager, Office of Safety Operations (Remote)

AbbVie Inc; North Chicago (IL); Remote; USD 80,000 - 130,000; Full time

Job summary

An innovative company is seeking a Manager for Safety Operations to enhance patient safety through effective pharmacovigilance processes. This role involves ensuring compliance with global regulations, leading a team, and collaborating across various departments to streamline operations. You will utilize your expertise to drive improvements and support audits while fostering a culture of excellence. If you're passionate about making a difference in healthcare and possess strong leadership skills, this opportunity offers a chance to significantly impact lives while working in a dynamic and supportive environment.

Benefits

Paid Time Off

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Short-term Incentive Programs

Long-term Incentive Programs

Qualifications

• 5+ years in the pharmaceutical industry, with 3 years in pharmacovigilance.
• Knowledge of ICH, EMA, and FDA regulations.
• Experience in audits and inspections.

Responsibilities

• Design and implement compliant ICSR pharmacovigilance processes.
• Lead improvements in clinical and post-marketing case management.
• Manage internal audits and regulatory inspections.

Skills

Pharmacovigilance

Regulatory Compliance

Data Interpretation

Stakeholder Management

Team Leadership

Education

Bachelor's Degree in Science

Tools

Excel

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.

Job Description

Purpose:

This position supports the Safety Operations organization in improving patient lives by ensuring high-quality, timely adverse event management and driving industry-leading ICSR operations, standards, and technology at AbbVie.

The Manager, Office of Safety Operations, is part of the ICSR Compliance department within Safety Operations.

This role is responsible for monitoring and ensuring compliance with global regulatory reporting of ICSRs, managing investigations into compliance deviations, and collaborating with license partners to align on reporting obligations and safety data exchange requirements.

The successful candidate will support internal and external audits and regulatory inspections by providing documentation, data analysis, and subject matter expertise related to ICSR processes.

Responsibilities:

1. Designs and implements compliant and efficient ICSR pharmacovigilance processes, technologies, and training.
2. Leads improvements in AbbVie's global clinical and post-marketing case management processes, technology, and training.
3. Implements new ICSR pharmacovigilance legislation into quality systems, metrics, technical requirements, and training.
4. Builds effective cross-functional collaboration with stakeholders including PPS, Commercial, GMA, RDQA, and Affiliates to harmonize ICSR processes.
5. Leads internal audits and external regulatory inspection activities, supporting corrective and preventive actions.
6. Supports PPS in understanding changing regulatory environments affecting ICSR management, processes, technology, and personnel.
7. Uses global data and insights to optimize ICSR operations, including designing training approaches.
8. Manages process improvement initiatives, change management, and issue resolution.
9. Identifies, prioritizes, and resolves impactful issues, communicating effectively across stakeholders.
10. Drives compliance and process excellence for all ICSR PV activities as a senior team member.
11. Presents results to senior stakeholders and participates in governance meetings.
12. Develops and manages a team of up to 5 staff, providing coaching and mentoring.

This role can be remote in the US.

Qualifications:

• Bachelor’s Degree or equivalent in a related science field; +5 years pharmaceutical industry experience, including at least 3 years in pharmacovigilance; global experience.
• Knowledge of global pharmacovigilance regulations (ICH, EMA, FDA) and quality assurance systems.
• Experience with health authority inspections and audits.
• Experience in developing training and quality documents (SOPs, guidelines, CAPAs).
• Skilled in data interpretation, proficient with Excel.
• Proficient in case processing processes and procedures.
• Ability to influence stakeholders and manage within a cross-functional matrix; collaborative approach.
• Ability to identify, assess, and manage business and compliance risks.
• Experience in leading cross-functional teams is preferred.
• Strong influencing skills.

Additional Information

• The compensation range is based on job grade, geographic location, and other factors; actual pay may vary.
• We offer comprehensive benefits, including paid time off, medical/dental/vision insurance, and 401(k).
• This role is eligible for short-term and long-term incentive programs.
• Pay is only considered wages or compensation once earned and vested; bonuses and benefits are at the company's discretion.

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