Global Safety Senior Medical Scientist

Employer
Amgen
Location
Thousand Oaks, California
Posted
Aug 10, 2018
Ref
R-60694
Required Education
Bachelors Degree
Position Type
Full time

The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.

The Global Safety Physician (GSP) serves as the medical expert of the team to support the GSO in the conduct of quality safety assessment and risk management processes and activities for an assigned set of products through the product's life cycle.

The GSP is responsible for the conduct of safety monitoring and accountable for executing all product related safety decisions and deliverables for assigned products as designated by GSO or TAH. Global Safety Officer may delegate to the Global Safety Physician where medical input is required.

The Global Safety Physician is responsible for the following:

  • Directs the planning, preparation, writing and review of portions of aggregate reports
  • Organize and direct liaison activities with affiliates and other internal Amgen partner regarding products
  • Supports and provides oversight to staff with regards to safety in clinical trials to:
  • Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
  • Review of AEs/SAEs from clinical trials as needed
  • 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
  • Participate in study team meetings as requested or needed
  • Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results
  • Documents work as required in the safety information management system
  • Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO
  • Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
  • 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:
  • Provides content for risk management plans
  • Develop or 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 in developing a strategy for safety-related regulatory activities
  • Provide safety contents for filings
  • 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
  • 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 in developing a strategy for safety-related regulatory activities
  • Provide safety contents for filings
  • 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

BASIC QUALIFICATIONS:

MD, DO or equivalent degree from an accredited medical school

Plus 2 years of work experience

And

Completion of an accredited medical or surgical residency

OR

Clinical experience in either an accredited academic setting or private practice (including hospital based) setting

PREFERRED QUALIFICATIONS:

  • Clinical/medical research experience
  • Experience completing product safety deliverables in the bio/pharmaceutical industry
  • Previous management and or mentoring experience
  • Experience in leading teams and or projects