Amgen Global Safety Senior Medical Scientist in Thousand Oaks, California

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.

Applicable tasks may vary by product(s) assigned and are performed under the supervision of the GSO. 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

SKILLS:

  • Processes and regulations for pharmacovigilance and risk management

  • Drug development and lifecycle management

  • Safety data capture in clinical development and post-market settings

  • Safety database structure and conventions

  • MedDRA and other dictionaries used in pharmacovigilance

  • Methods of qualitative and quantitative safety data analysis

  • Product and disease state knowledge

  • Risk management and risk minimization

  • Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labeling

  • Advanced understanding of interfaces across various pharmacovigilance and risk management processes

  • Internal organizational and governance structure

  • Pharmacovigilance skills-intermediate knowledge of the following:

  • Signal detection, evaluation and management

  • Aggregate data analysis, interpretation and synthesis

  • Good clinical and scientific judgment

  • Application of medical concepts and terminology

  • Document writing and source document review

  • Writing Risk Management Plans

  • Ability to convey complex, scientific data in an understandable way

  • Ability to analyze and interpret complex safety data

  • Intermediate skills in application of statistical and epidemiological methods to pharmacovigilance

  • Biomedical Literature-intermediate skills:

  • Literature Surveillance: source document review knowledge and skills

  • Literature search, evaluation and assessment skills-ability to search literature databases to identify safety literature for signal evaluation and assessment, interpretation and synthesis skills

  • Other skills-intermediate skills in the following

  • Organization, prioritization, planning skills

  • Collaboration with cross-functional team settings

  • Meeting management and time management skills

  • Process and project management

  • Critical scientific assessment and problem solving

  • Strong Written and verbal communications skills, including medical/scientific writing

  • Computer skills (e.g., MS Office Suite and safety systems)

  • Strategic thinking

  • Influencing and negotiation in a cross-functional, matrix environment

  • Presentation skills for conveying complex technical contents to non-expert audiences

KNOWLEDGE:

  • Broad PV knowledge with expertise within defined subject area

  • Applies knowledge and broad understanding of multiple disciplines

  • Understands impact of emerging scientific/technical trends and their implications for Amgen

  • PROBLEM SOLVING

  • Analyzes and forecasts scientific/technical trends

  • Develops solutions to problems through in-depth analysis, coordination and negotiation with key decision makers

  • Performs complex work-flow analysis on processes impacting multiple areas across the organization

  • Adapts and integrates own experience with Amgen-wide strategy

  • Develops innovative solutions to problems without precedent

  • Proposes new processes to achieve strategic business objectives

  • Works in partnership with GPS team to develop business plans that support the direction of the business

AUTONOMY:

  • Guided by business plans and strategy:

  • Executes strategy, goals and changes within area of responsibility

  • Contributes to strategic decisions affecting the discipline

  • Guides ideas through development into a final product

CONTRIBUTION:

  • Contributes to business results through quality of results, advice and decisions related to the operations of the discipline

  • Designs and develops global processes, systems and/or applications

  • Contributes to organization through leadership

  • May accomplish business results through leveraging a team of professionals and/or managers

  • Develops mutually beneficial strategic alliances with internal and external contacts

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

#LI-POSTMD01

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.