Senior Global Pharmacovigilance Leader

Amgen; Stati Uniti; In loco; USD 180.000 - 240.000; Tempo pieno

Descrizione del lavoro

Amgen seeks a Global Pharmacovigilance Senior Manager to lead advanced safety activities across therapeutic areas. The role involves guiding safety assessment, signal detection, and safety reporting for regulatory submissions, while ensuring collaboration with affiliates and internal teams.

You will oversee study safety data, contribute to risk management plans, and support inspections and regulatory inquiries. A strong PV background with leadership experience is required.

Competenze

• Pharmacovigilance professional with advanced degree(s) and relevant industry experience.
• Experience leading PV teams and safety signal detection activities.
• Strong record of safety reporting, risk management, and regulatory interactions.
• Knowledge of clinical trial safety data handling and regulatory standards.

Mansioni

• Directs safety assessment activities and safety data reviews.
• Oversees aggregate reporting planning, writing, and review.
• Liaises with affiliates and internal partners on product safety issues.
• Reviews AEs/SAEs from trials and supports safety data listings and reports.
• Develops safety-related data collection tools and forms.
• Performs safety signal detection, evaluation, and communication to cross-functional teams.
• Ensures inspection readiness and prepares responses to regulatory inquiries.

Conoscenze

Pharmacovigilance leadership

Data analysis

Safety reporting

Regulatory compliance

Formazione

Doctorate in pharmacovigilance

Master's in life sciences

Bachelor's degree

Associate's degree

High school diploma

Descrizione del lavoro

Amgen seeks a Global Pharmacovigilance Senior Manager to lead advanced safety activities across therapeutic areas. The role involves guiding safety assessment, signal detection, and safety reporting for regulatory submissions, while ensuring collaboration with affiliates and internal teams.

You will oversee study safety data, contribute to risk management plans, and support inspections and regulatory inquiries. A strong PV background with leadership experience is required.