Exception Template Pharmacovigilance Sr. Scientist

Location: Cambridge, MA
Date Posted: 02-10-2017
•TOP 3 SKILL SETS:
Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results
Support authoring of Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the Global Safety Officer
Directs the planning, preparation, writing and review of portions of aggregate reports

Job 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:
o Provides contents for risk management plans
o Develop or update strategy and content for regional risk management plans
o Assist GSOs to oversee risk minimization activities including tracking of activities as needed.
o 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
o Assist GSO in developing a strategy for safety-related regulatory activities
o 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 (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 

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