What are the responsibilities and job description for the Global Safety Manager position at Amgen?
Amgen is seeking a Global Safety Manager to work out of their Thousand Oaks, CA location.
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:
Clinical Nursing qualification and 1 year of related drug safety experience
Preferred Qualifications and Skills:
- Medical Qualification (Nursing Degree); plus 3 years relevant work
- 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 and patient population
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need 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, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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.
