Global Pharmacovigilance Leader: Patient Safety & Strategy

Regulatory Toolkit; United States; Híbrido; USD 116.000 - 157.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Retirement plan

Bonus program

Stock options

Paid time off

Descripción de la vacante

Amgen is seeking a Global Pharmacovigilance Manager to lead product safety surveillance and risk management across clinical development and post-marketing stages. You will partner with GSOs, Clinical Development, and Regulatory Affairs to shape safety strategies for an oncology-immunology portfolio with innovative therapies.

You will oversee aggregate safety reports, safety assessments, and cross-functional governance, while guiding junior scientists and ensuring inspection readiness.

Formación

• Doctorate degree or equivalent in a relevant field
• Advanced pharmacovigilance knowledge with hands-on experience
• Strong leadership in global safety governance and cross-functional teams
• Experience with signal detection, evaluation, and risk management
• Familiarity with regulatory requirements (FDA, EMA, ICH) and PV audits

Responsabilidades

• Lead product safety surveillance, signal detection, evaluation and management.
• Prepare and contribute to aggregate safety reports (PBRERs/PSURs/DSURs).
• Provide strategic safety input into clinical protocols and development plans.
• Represent Global Patient Safety in governance forums and cross-functional teams.
• Contribute to risk management plans, REMS, and regulatory safety strategies.
• Support regulatory submissions, inspections, and health authority responses

Conocimientos

Signal detection

Safety analysis

Risk assessment

Cross-functional leadership

Regulatory knowledge

Educación

Doctorate degree

Master’s degree and 2 years of Industry Pharmacovigilance experience

Bachelor’s degree and 4 years of Industry Pharmacovigilance experience

Herramientas

Argus Safety

Descripción del empleo

Amgen is seeking a Global Pharmacovigilance Manager to lead product safety surveillance and risk management across clinical development and post-marketing stages. You will partner with GSOs, Clinical Development, and Regulatory Affairs to shape safety strategies for an oncology-immunology portfolio with innovative therapies.

You will oversee aggregate safety reports, safety assessments, and cross-functional governance, while guiding junior scientists and ensuring inspection readiness.