Job 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.

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