Global Pv Scientist

1 day ago

Hyderabad Telangana, India Amgen Full time

**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
- 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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