Global Pharmacovigilance Senior Manager: Lead Safety

BioSpace; Washington (District of Columbia); Presencial; USD 140.000 - 190.000; Jornada completa

Descripción de la vacante

Amgen in Washington, DC seeks a Global Pharmacovigilance Senior Manager to lead safety assessment activities within Therapeutic Safety Teams and oversee pharmacovigilance operations across products.

The role emphasizes planning, review of aggregate safety data, risk management, regulatory submissions, and cross-functional collaboration to protect patient safety and maintain inspection readiness.

Formación

• Pharmacovigilance experience in industry aligned to degree level.
• Demonstrated understanding of safety reporting and regulatory expectations.
• Experience across multiple PV activities and cross-functional collaboration.

Responsabilidades

• Directs planning, preparation, writing and review of aggregate safety reports.
• Oversees liaison activities with affiliates and internal Amgen partners on product safety.
• Reviews AEs/SAEs and contributes to study safety data listings and tables.
• Contributes to study risk management and regulatory safety responses.
• Supports inspection readiness and regulatory inquiries related to PV activities.

Educación

Doctorate degree

Masters degree

Bachelor's degree

Associates degree

High school diploma/GED

Descripción del empleo

Amgen in Washington, DC seeks a Global Pharmacovigilance Senior Manager to lead safety assessment activities within Therapeutic Safety Teams and oversee pharmacovigilance operations across products.

The role emphasizes planning, review of aggregate safety data, risk management, regulatory submissions, and cross-functional collaboration to protect patient safety and maintain inspection readiness.