Global PV Scientist Full-time

Safety Pv Scientist Manager

The PV Scientist Manager is responsible for the following:

• Contributes to the planning, preparation, writing and review of non-medical portions of aggregate reports
• Works with affiliates and other internal Amgen partners regarding deliverables
• Review of AE/SAEs from clinical trials as needed

Contributes under the direction of the Global PV Sr. Scientist or Lead to:

• Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
• Review standard design of tables, figures, and listings for safety data from clinical studies
• Participate in development of safety-related data collection forms for clinical studies
• Attend study team meetings as requested or needed
• Conduct signal detection, evaluation, and management
• Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO
• Prepare safety assessment reports and other safety documents and regulatory responses
• Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
• Participates in Safety Governance per Amgen processes
• Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional decision-making body
• Assist GSOs and other Senior Scientists in the development of risk management strategy and activities
• Provides contents for risk management plans
• Update strategy and content for regional risk management plans
• Assist GSOs to oversee risk minimization activities including tracking of activities as needed
• Evaluate risk minimization activity
• Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
• Support activities related to new drug applications and other regulatory filings
• Assist GSO/ or other Senior Scientist in developing a strategy for safety-related regulatory activities
• Provide safety contents for filings
• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

Inspection Readiness:

• Undertake activities delegated by the QPPV as detailed in the 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

The PV Scientist contributes to GPS in the following ways:

• Contribute to the development, improvement, and standardization of pharmacovigilance processes and methods
• Participates on teams for the implementation of new processes and methods within the Therapeutic Area

Basic Qualifications and Experience:

• Master's or Bachelor's degree with minimum 9+ years of experience in relevant fields