Senior Oncology Patient Safety Director

AbbVie; Florham Park (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

AbbVie in Florham Park, NJ is seeking a Lead for the Product Safety Team overseeing late-stage oncology safety across the product lifecycle. You will work with development medical leads, PK/tox, regulatory, and clinical teams to guide dose selection, inclusion criteria, and safety monitoring for first-in-human trials and PMOS/NDA-related activities.

The role requires MD/DO with oncology safety experience, strong PV background, and ability to lead cross-functional teams in a high-pace

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.
• Experience supporting regulatory submissions (IND/BLA) is required.
• Oncology patient safety experience is required.

Responsibilities

• Understand and apply pharmacology, chemistry and non-clinical toxicology to safety surveillance.
• Lead safety surveillance for pharmaceutical/biological products.
• Lead strategy for PV documents including medical safety assessments and risk management plans.
• Apply regulatory guidance to safety surveillance and PV document authorship.
• Analyze and present safety data to cross-functional teams and leadership.
• Write/review technical PV documents and provide input.
• Lead periodic safety reports (DSURs, PSURs, PADERs).
• Implement risk management strategies for assigned products.
• Mentor and coach team members.
• Opportunity to co-author publications.
• Be a strong team player in a fast-paced environment.

Skills

Pharmacovigilance

Regulatory submissions

Oncology safety

Clinical development

Cross-functional collaboration

Medical writing

Team leadership

Data analysis

Education

MD/DO

PhD or Clinical Pharmacology fellowship

Internal medicine residency

IND/BLA submissions experience

Oncology clinical experience

Job description

AbbVie in Florham Park, NJ is seeking a Lead for the Product Safety Team overseeing late-stage oncology safety across the product lifecycle. You will work with development medical leads, PK/tox, regulatory, and clinical teams to guide dose selection, inclusion criteria, and safety monitoring for first-in-human trials and PMOS/NDA-related activities.

The role requires MD/DO with oncology safety experience, strong PV background, and ability to lead cross-functional teams in a high-pace