What you will do
Let’s do this. Let’s change the world. In this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise to Global Patient Safety (GPS).
- Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection.
- Perform data analysis to evaluate safety signals and write up analysis results.
- Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the Global Safety Officer (GSO).
- Direct the planning, preparation, writing and review of safety portions of aggregate reports.
- Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body.
- Assist GSO in the development of risk management strategy and activities: Provide contents for risk management plans; Develop or update strategy and content for regional risk management plans;
- Assist GSOs to coordinate risk minimization activities including tracking of activities; 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 in developing a strategy for safety-related regulatory activities; Provide safety contents for filings.
- Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products.
- Provide support for clinical trials to review and provide input to study-related documents (e.g., study protocols; statistical analysis plans; safety-related data collection forms; and design of tables, figures, and listings for safety data from clinical studies) and provide aggregate review of Adverse Events (AEs)/Serious Adverse Events (SAEs) from clinical trials.
- Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (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.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of proven experience
OR
Master’s degree and 4 years of proven experience
OR
Bachelor’s degree and 6 years of proven experience
OR
Associate’s degree and 10 years of proven experience
OR
High school diploma / GED and 12 years of proven experience
Preferred Qualifications:
- RN, PharmD, MPH or PA
- Extensive direct experience in pharmacovigilance: signal detection and evaluation; data analysis interpretation and synthesis; periodic report production
- Knowledge of processes and regulations for pharmacovigilance and risk management
- Clinical/medical research experience
