Senior Oncology Safety Director — PV Strategy

AbbVie; North Chicago (IL); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

401(k)

Health insurance

Long-term incentive programs

Paid time off

Job summary

AbbVie in North Chicago, IL is seeking an experienced PST Lead for oncology safety to shape lifecycle safety strategy across programs. You will partner with medical, regulatory and development teams to guide dose selection, PV documentation and regulatory responses across NDA/sNDA submissions.

The role requires MD/DO with PV experience, strong cross-functional leadership and the ability to communicate complex safety data to senior stakeholders.

Qualifications

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

Responsibilities

• Safety surveillance for pharmacovigilance across oncology products.
• Lead strategy for PV documents and risk management plans (DSURs/PSURs/PADERs) for NDA/sNDA submissions.
• Collaborate with regulatory, PK/toxicology, medical affairs and development teams to guide safety monitoring and dose selection.

Skills

Pharmacovigilance

Clinical Development

Regulatory submissions

Oncology safety

Cross-functional leadership

Education

MD/DO with 2+ years internal medicine residency

PhD or Clinical Pharmacology fellowship (preferred)

Job description

AbbVie in North Chicago, IL is seeking an experienced PST Lead for oncology safety to shape lifecycle safety strategy across programs. You will partner with medical, regulatory and development teams to guide dose selection, PV documentation and regulatory responses across NDA/sNDA submissions.

The role requires MD/DO with PV experience, strong cross-functional leadership and the ability to communicate complex safety data to senior stakeholders.