**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.**