Senior Oncology Patient Safety Lead

PowerToFly; North Chicago (IL); On-site; USD 180,000 - 250,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Job summary

AbbVie is seeking a Product Safety Team (PST) lead for late-stage oncology to drive strategy and ensure safety across the product lifecycle, coordinating with safety scientists and cross-functional colleagues.

You will guide dose selection, safety monitoring for trials, and PV submissions while collaborating with PK, toxicology, regulatory, clinical development, and medical affairs to shape development programs.

Qualifications

• MD/DO with 2+ years of internal medicine residency and patient management experience.
• PhD or Clinical Pharmacology fellowship is preferred in addition to MD/DO.
• 2-5 years of Pharmacovigilance/Clinical Development experience in the pharmaceutical industry.
• Experience supporting regulatory submissions (IND/BLA) is required.
• Oncology patient safety experience is required.
• Ability to lead cross-functional teams and communicate recommendations.

Responsibilities

• Understand and apply pharmacology and non-clinical toxicology to safety surveillance.
• Lead safety surveillance for pharmaceutical/biological/drug–device products.
• Lead strategy for pharmacovigilance documents including safety assessments and risk management plans.
• Apply current regulatory guidance for PV surveillance and document authorship.
• Analyze and interpret aggregate safety data and communicate findings to stakeholders.
• Write and review technical safety documents independently.
• Oversee and lead periodic reports (DSURs, PSURs, PADERs, etc.).
• Implement risk management strategies for assigned products.
• Mentor and collaborate with cross-functional teams; contribute to publications.
• Adapt to a fast-paced environment as a strong team player.

Skills

Cross-functional leadership

Pharmacovigilance

Regulatory submissions

Safety signal detection

Education

MD/DO

PhD or Clinical Pharmacology fellowship

Job description

AbbVie is seeking a Product Safety Team (PST) lead for late-stage oncology to drive strategy and ensure safety across the product lifecycle, coordinating with safety scientists and cross-functional colleagues.

You will guide dose selection, safety monitoring for trials, and PV submissions while collaborating with PK, toxicology, regulatory, clinical development, and medical affairs to shape development programs.