Global Safety Senior Manager, Rare Disease

Role Summary

Global Safety Senior Manager, Rare Disease

Responsibilities

• 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‚Äôs 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.

Qualifications

• Basic Qualifications:
  • Doctorate degree and 2 years of proven experience
  • OR Master‚Äôs degree and 4 years of proven experience
  • OR Bachelor‚Äôs degree and 6 years of proven experience
  • OR Associate‚Äôs 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

Skills

• Pharmacovigilance and risk management knowledge
• Data analysis, signal detection, and interpretation
• Regulatory filing and safety documentation
• Clinical trial safety review and aggregate data analysis

Education

• Not specified beyond Basic Qualifications (see above).