Global Immunology Patient Safety Lead

BioSpace; North Chicago (IL); Hybrid; USD 180,000 - 230,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Job summary

AbbVie is seeking a senior Indication Pharmacovigilance Lead based in the United States. The role collaborates with development medical leads to set safety strategy across product lifecycles, leading PV documents, RMPs, PSURs, and NDA/sNDA supports.

The candidate should have MD/DO with extensive patient safety leadership experience, strong regulatory engagement, and immunology exposure to guide cross-functional teams in a fast-paced setting.

Qualifications

• MD/DO with 2+ years of patient management experience required.
• 5+ years of patient safety experience in the pharmaceutical industry, including leadership experience.
• Involvement in regulatory submissions or other regulatory interactions preferred.
• Immunology/Internal medicine experience strongly preferred.

Responsibilities

• Analyze and interpret aggregate safety data and communicate results to cross-functional teams.
• Lead strategy for pharmacovigilance documents and risk management plans.
• Apply regulatory guidance for safety surveillance and PV document authorship.
• Collaborate with regulatory, clinical development and medical affairs teams to support asset strategy.

Skills

Cross-functional leadership

PV data interpretation

Regulatory communication

Technical writing

Education

MD/DO

Job description

AbbVie is seeking a senior Indication Pharmacovigilance Lead based in the United States. The role collaborates with development medical leads to set safety strategy across product lifecycles, leading PV documents, RMPs, PSURs, and NDA/sNDA supports.

The candidate should have MD/DO with extensive patient safety leadership experience, strong regulatory engagement, and immunology exposure to guide cross-functional teams in a fast-paced setting.