Signal Management Scientist

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.

Advancing science and helping patients - these dual passions are ingrained in our culture. They drive our work, our values, and everything we do at Amgen. For staff around the world, our mission to serve patients and our commitment to science makes Amgen a place where we can make a positive difference in people's lives while pursuing a challenging and fulfilling career. To foster a setting in which all staff may excel, we support a variety of growth opportunities-from training and education to expanding current job responsibilities.

Amgen is searching for a Global Safety Mgr 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 & 3 years of Safety or Pharmacovigilance or Signal management experience
OR
Bachelor's Degree & 5 years of Safety or Pharmacovigilance or Signal management experience
OR
Associate's degree & 10 years of Safety or Pharmacovigilance or Signal management experience
OR
High school diploma/GED & 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 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.

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.