Manager, Office of Safety Operations (Remote)

BioSpace; North Chicago (IL); Remote; USD 100,000 - 130,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Manager for the Office of Safety Operations. This remote role focuses on improving patient lives through effective adverse event management and compliance. The ideal candidate will have extensive experience in pharmacovigilance and a strong understanding of regulatory requirements. You will lead a team, drive process improvements, and collaborate with various stakeholders to enhance operational standards. Competitive compensation and benefits are offered.

Benefits

Paid Time Off

Insurance

401(k)

Participation in incentive programs

Qualifications

• Minimum of 5 years of pharmaceutical industry experience, including 3 years in pharmacovigilance.
• Knowledge of global pharmacovigilance regulations (ICH, EMA, FDA).

Responsibilities

• Designs and implements compliant ICSR pharmacovigilance processes.
• Leads improvements in global clinical and post-marketing case management.
• Supports audits and inspections, leading corrective actions.

Skills

Pharmacovigilance

Stakeholder Management

Data Interpretation

Education

Bachelor’s Degree in a related science field

Tools

Excel

Job description

Manager, Office of Safety Operations (Remote)

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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, as well as products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow us on social media: @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.

Purpose

This position supports the Safety Operations organization to achieve its mission of improving patient lives by delivering 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. The role involves monitoring and ensuring compliance with global regulatory reporting of ICSRs, managing investigations for compliance deviations, and supporting audits and inspections.

Responsibilities

• Designs and implements compliant and efficient ICSR pharmacovigilance processes, technologies, and training.
• Leads improvements in global clinical and post-marketing case management processes, technology, and training.
• Implements new legislation into quality systems, metrics, technical requirements, and training.
• Leads cross-functional collaboration with stakeholders including PPS, Commercial, GMA, RDQA, and Affiliates to harmonize ICSR processes.
• Supports audits and inspections, and leads corrective and preventive actions.
• Advises on regulatory environment changes impacting ICSR management.
• Utilizes global data and insights to optimize ICSR operations and training.
• Manages process improvement initiatives with change management strategies.
• Addresses impactful issues with clear communication and resolution strategies.
• Presents findings to senior stakeholders and maintains strong relationships across teams.
• Develops and manages a team of up to 5 staff, including coaching and mentoring.

Qualifications

• Bachelor’s Degree or equivalent in a related science field.
• Minimum of 5 years of pharmaceutical industry experience, including 3 years in pharmacovigilance.
• Knowledge of global pharmacovigilance regulations (ICH, EMA, FDA).
• Experience with health authority inspections and audits.
• Proficiency in developing SOPs, guidelines, and CAPAs.
• Skilled in data interpretation and Excel.
• Proficient in case processing processes and procedures.
• Strong influencing and stakeholder management skills.
• Experience in leading cross-functional teams preferred.

Additional Information

This role can be remote in the US. Compensation ranges vary based on location and experience. Benefits include paid time off, insurance, 401(k), and participation in incentive programs. AbbVie is an equal opportunity employer committed to diversity and inclusion.