Senior Medical Director, Patient Safety

Job overview

The Senior Medical Director, Patient Safety role is onsite in North Chicago, IL. Compensation is not specified. The role supports AbbVie's Product Safety Team and its mission to develop innovative medicines and solutions for serious health issues. The position leads patient-safety strategy and pharmacovigilance for late-stage oncology products across their lifecycle. It works with clinical development, pharmacology, toxicology, regulatory, and medical affairs colleagues to assess safety data, guide risk management, and support regulatory submissions and product labeling.

What you'll do

• Lead safety surveillance for assigned pharmaceutical, biological, and drug-device products
• set strategy for pharmacovigilance documents and regulatory responses
• apply regulatory guidance
• analyze and communicate aggregate safety data
• write and review technical documents
• oversee periodic safety reports
• implement risk-management strategies
• coach and mentor colleagues
• contribute to safety components of regulatory submissions and labeling.

What we're looking for

Skills & competencies

full-time

senior medical director

patient safety

north chicago il

abbvie

oncology

pharmacovigilance

safety surveillance

risk management

regulatory submissions

clinical development

md or do

Work arrangement

• Weekend coverage required

Benefits & perks

• Paid time off, holidays, sick leave, medical, dental, and vision insurance, 401(k), and eligibility for long-term incentive programs.

Why this role

Requires an MD or DO, internal medicine residency with patient-management experience, oncology patient-safety experience, pharmacovigilance or clinical-development experience, and prior regulatory-submission support.

About the employer

AbbVie is hiring for this role. Industry: Biological Product (except Diagnostic) Manufacturing. Sector: 32.