Global Safety Manager

Amgen is seeking a Global Safety Manager to join our team and work from Amgen's beautiful Thousand Oaks, CA or could possibly work remotely. To learn more about this position:

The Global Safety Manager provides medical review of individual safety case reports (ICSR) and or ICSRs for products with an established safety profile in support of safety surveillance for Amgen products. To support global individual case safety regulatory reporting compliance.

The responsibilities of the Global Safety Manager include:

• Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports
• Produce medically accurate ICSRs reports
• Execute medical triage for appropriate causality assessment on ICSRs and timely regulatory reporting
• Execute ICSR case escalation to Senior Medical Reviewer
• Execute appropriate case follow up per SOPs
• Support medical coding conventions, data collection methods, and systematic process improvements for AE processing
• Support training to Amgen employees on ICSR medical review
• Participate in Safety Assessment Team (SAT) as requested
• Provide expertise and guidance on teams for interdepartmental and cross-functional initiatives including, process improvement standards development, Standard Operating Procedure/Manual (SOP/MAN) creation, and metrics with regards to medical review and case management
• Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (PV) System Master File and maintain a state of inspection readiness
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Basic Qualifications:

Doctorate degree
OR
Master's degree and 3 years of scientific or drug safety experience
OR
Bachelor's degree and 5 years of scientific or drug safety experience
OR
Associate's degree and 10 years of scientific or drug safety experience
OR
High school diploma / GED and 12 years of scientific or drug safety experience

Preferred Qualifications:

• BS Degree
• Knowledge of Amgen Case Management and medical review SOPs and pharmacovigilance regulatory requirements for Pharmacovigilance
• Clinical knowledge of therapeutic area patient populations and drug class
• Proficiency in technical safety systems including Safety Database and medical coding
• Knowledge of safety data capture in Clinical Trials and Post Marketing setting
• Knowledge of clinical trials and drug development
• Knowledge of Amgen products

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen focuses on areas of high unmet medical needs and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.