Amgen Inc. is seeking a Global PV Scientist to provide key contributions to pharmacovigilance activities. In this role, you will support the preparation of aggregate reports, review clinical trial data, participate in signal detection and management, and help maintain inspection readiness.
What You'll Do
- Contribute to the planning, preparation, writing, and review of non-medical portions of aggregate reports.
- Work with affiliates and other internal Amgen partners regarding deliverables.
- Review AE/SAEs from clinical trials as needed.
- Review and provide input 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.
- 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 signal detection.
- Participate in Safety Governance per Amgen processes.
- Prepare presentations of the Global Safety Team’s recommendations on safety issues to cross-functional decision-making bodies.
- Assist GSOs and other Senior Scientists in the development of risk management strategy and activities.
- Provide contents for risk management plans.
- Update strategy and content for regional risk management plans.
- Assist GSOs to oversee and track risk minimization activities.
- Evaluate risk minimization effectiveness.
- Prepare responses to regulatory inquiries related to risk management plans under GSO guidance.
- 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.
- Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness.
- Be a representative and point of contact for Health Authority Inspections and Internal Process Audits within your remit.
- Contribute to the development, improvement, and standardization of pharmacovigilance processes and methods.
- Participate on teams for the implementation of new processes and methods within the Therapeutic Area.
What We're Looking For
- Master’s or Bachelor's degree.
- Minimum 9+ years of experience in relevant fields.
Team & Environment
This position works under the direction of the Global PV Sr. Scientist or Lead.
Amgen Inc. is an equal opportunity employer.
