Description
**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.**
