Global Medical Director — Neuroscience Patient Safety

Regulatory Toolkit; Chicago (IL); In loco; USD 180.000 - 240.000; Tempo pieno

Vantaggi offerti da questo lavoro

Paid time off

Insurance (medical/dental/vision)

401(k)

Descrizione del lavoro

AbbVie in the United States seeks a Pharmacovigilance Lead to oversee safety surveillance and risk management for multiple products across the lifecycle. You will lead PSTs, interpret safety data, and ensure regulatory compliance.

Responsibilities include drafting medical safety assessments, DSURs, PSURs, PADERs, coordinating cross-functional teams, mentoring staff, and communicating findings to regulators. Fluency in English is required; MD/DO with residency is preferred, MPH encouraged.

Competenze

• MD/DO with residency experience in patient management.
• Strong background in pharmacovigilance and clinical development.
• Fluency in English (written and spoken).

Mansioni

• Lead safety surveillance and pharmacovigilance for products in development and in market.
• Oversee key pharmacovigilance documents (DSURs, PBRERs/PSURs, PADERs).
• Analyze and interpret aggregate safety data; communicate to cross-functional teams and regulators.
• Write, review, and present technical safety documents.
• Implement risk management strategies for assigned products.
• Mentor and coach PST members and colleagues.

Conoscenze

Pharmacovigilance

MD/DO

Clinical development

Formazione

MD/DO degree

Master of Public Health (preferred)

Descrizione del lavoro

AbbVie in the United States seeks a Pharmacovigilance Lead to oversee safety surveillance and risk management for multiple products across the lifecycle. You will lead PSTs, interpret safety data, and ensure regulatory compliance.

Responsibilities include drafting medical safety assessments, DSURs, PSURs, PADERs, coordinating cross-functional teams, mentoring staff, and communicating findings to regulators. Fluency in English is required; MD/DO with residency is preferred, MPH encouraged.