Senior Oncology Patient Safety Leader – PV Strategy

Regulatory Toolkit; Chicago (IL); On-site; USD 180,000 - 240,000; Full time

Job summary

AbbVie in Chicago seeks a Product Safety Team Lead for late-stage oncology programs. You will oversee safety surveillance across the product lifecycle, guiding dose selection and safety monitoring in early trials in collaboration with PK, toxicology, regulatory and medical affairs teams.

You will interpret pharmacovigilance regulations, lead PV documentation strategy for NDA/sNDA submissions and risk management plans, and mentor colleagues in a fast-paced environment.

Qualifications

• MD/DO with 2+ years of internal medicine residency and patient management experience.
• Pharmacovigilance/Clinical Development experience in pharma industry.
• Oncology patient safety experience required.
• Experience supporting regulatory submissions (IND/BLA).

Responsibilities

• Conduct safety surveillance by applying pharmacology, chemistry and non-clinical toxicology.
• Lead safety surveillance for pharmaceutical/biological/drug-device products.
• Set strategy for PV documents, including PSURs and NDA/sNDA safety components.
• Apply regulatory guidance for PV document authorship.
• Analyze aggregate safety data and communicate to cross-functional teams and leadership.
• Write and review technical PV documents.
• Oversee periodic reports (DSURs, PSURs, PADERs).
• Implement risk management strategies for assigned products.
• Mentor and lead team; collaborate cross-functionally.
• Co-author publications and participate in safety leadership initiatives.
• Adapt in fast-paced environment.

Skills

Pharmacovigilance

Regulatory submissions

Oncology safety

Cross-functional leadership

Medical affairs collaboration

Education

MD/DO with residency

Clinical Pharmacology fellowship preferred

Job description

AbbVie in Chicago seeks a Product Safety Team Lead for late-stage oncology programs. You will oversee safety surveillance across the product lifecycle, guiding dose selection and safety monitoring in early trials in collaboration with PK, toxicology, regulatory and medical affairs teams.

You will interpret pharmacovigilance regulations, lead PV documentation strategy for NDA/sNDA submissions and risk management plans, and mentor colleagues in a fast-paced environment.