Global PV Safety Leader – Senior Manager

Amgen; Newark (NJ); Ibrido; USD 141.000 - 190.000; Tempo pieno

Vantaggi offerti da questo lavoro

Retirement plan contributions

Medical, dental, vision coverage

Stock-based long-term incentives

Annual bonus program

Descrizione del lavoro

Amgen is a global biotechnology company focused on serving patients with serious illnesses. We are looking for a Global Pharmacovigilance Senior Manager to lead safety assessment activities, oversee AEs/SAEs review, and coordinate with affiliates and internal partners.

The role involves risk management planning, regulatory support, and inspection readiness. The position requires advanced degrees and substantial pharmacovigilance experience, including leadership and staff oversight.

Competenze

• Doctorate degree with industry pharmacovigilance experience required.
• Masters with industry pharmacovigilance experience acceptable.
• Bachelor’s degree with 6+ years in pharmacovigilance would qualify.
• Associate’s degree with 10 years in pharmacovigilance acceptable.
• High school diploma with 12 years in pharmacovigilance acceptable.

Mansioni

• Directs planning, preparation, writing and review of safety reports.
• Oversees liaison with affiliates and internal Amgen partners on products.
• Supports staff regarding safety in clinical trials and study docs.
• Reviews adverse events from trials and safety data tables.
• Develops safety-related data collection forms and participates in study teams.
• Signals detection, evaluation and management; analyzes safety data.

Conoscenze

Leadership

Project management

Pharmacovigilance

Formazione

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Descrizione del lavoro

Amgen is a global biotechnology company focused on serving patients with serious illnesses. We are looking for a Global Pharmacovigilance Senior Manager to lead safety assessment activities, oversee AEs/SAEs review, and coordinate with affiliates and internal partners.

The role involves risk management planning, regulatory support, and inspection readiness. The position requires advanced degrees and substantial pharmacovigilance experience, including leadership and staff oversight.