Head of Oncology Pharmacovigilance

Actox; Boston (MA); Hybrid; USD 180,000 - 280,000; Full time

Job summary

AbbVie seeks a senior medical director to lead Product Safety Teams (PST) and oversee safety across product lifecycles, including surveillance, signal detection, and risk management plans. The role requires MD/DO with extensive pharmacovigilance and cross-functional leadership experience, and fluency in English.

Responsibilities include strategy development for PV documents, PSURs/PADERs, and coordination of safety activities in trials and post-marketing.

Qualifications

• MD/DO with 2+ years of residency with patient management experience.
• Master Public Health is preferred in addition to MD/DO, not required
• 8 - 10 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
• Effectively analyze and guide analysis of clinical data and epidemiological information
• Effectively present recommendations / opinions in group environment both internally and externally
• Write, review and provide input on technical documents
• Work collaboratively and lead cross-functional teams
• Ability to lead cross-functional teams in a collaborative environment
• Fluency, both written and oral, in English
• Evaluate and make independent decisions. Ability to work effectively in the situation of uncertainty and complexity, ability to multitask

Responsibilities

• Understand and apply pharmacology, chemistry and non-clinical toxicology for safety surveillance
• Responsible for safety surveillance for products
• Lead strategy for pharmacovigilance documents and risk management plans
• Apply regulatory guidance for PV documents
• Analyze and interpret aggregate safety data and communicate to cross-functional teams
• Lead PSURs, PADERs and related reports
• Oversee safety surveillance for products in trials and post-marketing
• Implement risk management strategies for assigned products
• Mentor and coach team members
• Coordinate safety activities across indications and products

Skills

MD/DO residency

Leadership

Pharmacovigilance

Cross-functional leadership

English fluency

Education

MD/DO degree

Master of Public Health (preferred)

Job description

AbbVie seeks a senior medical director to lead Product Safety Teams (PST) and oversee safety across product lifecycles, including surveillance, signal detection, and risk management plans. The role requires MD/DO with extensive pharmacovigilance and cross-functional leadership experience, and fluency in English.

Responsibilities include strategy development for PV documents, PSURs/PADERs, and coordination of safety activities in trials and post-marketing.