Global Safety/Signal Management Scientist

Amgen is searching for a Global Safety Manager that will function as a Signal Management Scientist on our Global Patient Safety Labeling & Pediatrics team as part of our Safety Management Group. This role will be based on main corporate campus in Thousand Oaks, CA and will report to the Global Safety Senior Manager.

The Signal Management Scientist guides and maintains Amgen safety signal management processes and activities reporting to the Safety Management Officer. This Scientist ensures that safety signal management processes are continuously improved to reflect regulatory trends and guidelines and represent best in class. In addition, this Scientist supports the Signal Management Officer in developing and maintaining signal management processes and metrics to maximize patient safety.

Essential duties for the Signal Management Scientist include:

Signal Management

• Ensure Amgen adheres to and is aligned with Global Health Authority regulations regarding signal management practices
• Support creation of signal management strategy for department; ensure staff adheres to signal detection by generating metrics reports
• Serve as an expert for internal signal tracking tool
• Support oversight of Data mining process. Implementation of data mining. Oversee data mining runs and tracking outputs and signals.
• Maintains respective standards and schedules, and ensures state of the art signal detection methodology
• Proactively develop proposals for signal detection and optimal functioning between vendors and Safety
• Serve as a Subject Matter Expert on Signal management and Safety Governance for stakeholders internal and external to Global Patient Safety
• Contributes to cross-functional initiatives aimed to improve pharmacovigilance capabilities related to signal detection
• Inform teams of new or revised regulatory requirements and guidelines relevant to PV Signal Management
• Train staff on data mining and signal management
• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by leadership

Metrics / Quality

• Support creation of signal metrics and reports for management
• Contribute to the development of Performance Indicators
• Monitoring for safety agreement terms relevant to vendors and partners
• Monitors performance (KPIs KCIs) and quality metrics
• Manages deviations to completion
• Participates in initiatives targeted at improving process quality, effectiveness and creating a team culture of continuous improvement

Inspection/Audit

• Support inspection and audit activities
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Be a representative 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 Safety or Pharmacovigilance or Signal management experience
OR
Bachelor's Degree and 5 years of Safety or Pharmacovigilance or Signal management experience
OR
Associate's degree and 10 years of Safety or Pharmacovigilance or Signal management experience
OR
High school diploma/GED and 12 years of Safety or Pharmacovigilance or Signal management experience.

Preferred Qualifications

• Pharmaceutical industry or health authority experience.
• Pharmacovigilance processes and EU, FDA and international regulatory requirements
• Safety Information tracking and pharmacovigilance systems
• Experience in supporting inspections or internal audits
• Understanding of commercial processes and vendor interactions
• Written and oral communications, leadership and problem solving
• Quantitative and qualitative signal detection methodologies and safety data analysis

Doctorate degree and 2 years of pharmacovigilance or signal management experience OR Master's degree and 6 years of pharmacovigilance or signal management experience OR Bachelor's degree and 8 years of pharmacovigilance or signal management experience OR
Associate's degree and 10 years of pharmacovigilance or signal management experience OR High school diploma / GED and 12 years of pharmacovigilance or signal management experience.

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.

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.