Pharmacovigilance Sr. Scientist

Location: Cambridge, MA
Date Posted: 01-11-2018
Day to Day Responsibilities:     
product and program understanding, becomes a key contributor on program deliverables

Preferred:
RN, PharmD or PA Clinical/medical research experience Processes and regulations for pharmacovigilance and risk management Aggregate data analysis, interpretation and synthesis Signal detection, evaluation and management 6 years of experience in a biotech/pharmaceutical setting

Summary:
The PV Sr. Scientist works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations.

Key Activities:
Applicable tasks may vary by product(s) assigned. The PV Sr. Scientist is responsible for the following:
  • Planning, preparation, writing and review of portions of aggregate reports
  • Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products
  • Supports and provides oversight to staff with regards to safety in clinical trials to: o 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
  • 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
  • Support authoring of 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 contents 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 o 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
Knowledge and 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 organizational 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
Education & Experience (Basic):
Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Education & Experience

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