Senior Immunology Pharmacovigilance Lead

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

Job summary

AbbVie is seeking an Indication Pharmacovigilance Safety Lead to guide safety strategy across development and life-cycle for multiple indications. You will collaborate with medical, regulatory, epidemiology and clinical teams to deliver robust safety assessments and risk management plans.

Responsibilities include leading PV documents, coordinating DSURs/PSURs, ensuring regulatory compliance, and mentoring safety colleagues.

Qualifications

• MD/DO with 2+ years patient management experience.
• 5+ years patient safety in pharma, with leadership experience.
• Experience in regulatory submissions for marketing authorizations.
• Experience in pharmaceutical clinical development.
• Immunology/internal medicine experience preferred.
• Ability to lead cross-functional teams in a collaborative environment.

Responsibilities

• Analyze aggregate safety data and present findings to teams and leadership.
• Lead strategy for pharmacovigilance documents and safety components of submissions.
• Apply regulatory guidance for PV surveillance and PV document authorship.
• Collaborate with safety, regulatory, clinical, and medical affairs teams.
• Lead and mentor safety team members and co-author publications.
• Oversee periodic safety reports (DSURs, PSURs, PADERs).

Skills

Patient safety leadership

Regulatory submissions

Cross-functional leadership

Immunology experience

Clinical data analysis

Education

MD/DO

Job description

AbbVie is seeking an Indication Pharmacovigilance Safety Lead to guide safety strategy across development and life-cycle for multiple indications. You will collaborate with medical, regulatory, epidemiology and clinical teams to deliver robust safety assessments and risk management plans.

Responsibilities include leading PV documents, coordinating DSURs/PSURs, ensuring regulatory compliance, and mentoring safety colleagues.