Pharmacovigilance Sr. Scientist

Thousand Oaks, CA 91320

Posted: 02/13/2017 Employment Type: Contract Job Number: 2438

We are looking for a Safety Scientist  who would be passionate about the opportunity to work on   a therapeutic agent that will bring significant improvement to the patient population' s needs.  

Job Summary:
The Pharmacovigilance  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 company  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

• 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

• 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 company-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

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

• 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:
Doctorate degree and 2 years of directly related experience
Master’s degree and 6 years of directly related experience
Bachelor’s degree and 8 years of directly related experience
Associate’s degree and 10 years of directly related experience
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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