Pharmacovigilance Safety Scientist

Location: Thousand Oaks, CA
Date Posted: 06-14-2017
Day to Day Responsibilities:     
Assessing aggregate data drafting safety summaries signal detection activities

Summary:
Ideal candidate would be someone within the Biopharmaceutical background, Degree in nursing, Pharm-D. Experience with drug safety, risk management, clinical trials setting. Excellent communication skills both oral and written. Basic skills in application of statistical and epidemiological methods to pharmacovigilance, Ability to convey complex, scientific data in an understandable way, Ability to analyze and interpret complex safety data, Participate in development of safety-related data collection forms for clinical studies
Global Safety Mgr
Title (Role) Global Pharmacovigilance (PV) Scientist
PV Activity Yes
Organization Global Patient Safety & Labeling
Function TA Safety
Team

Group Purpose 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.
Job Summary The Global PV Scientist Manager works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise as needed to GPS.

Key Activities Applicable tasks may vary by product(s) assigned.
The PV Scientist Manager is responsible for the following:
• Contributes to the planning, preparation, writing and review of non-medical portions of aggregate reports
• Works with affiliates and other internal Amgen partners regarding deliverables
• Review of AE/SAEs from clinical trials as needed
• Contributes under the direction of the Global PV Sr. Scientist or Lead to:
o Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
o Review standard design of tables, figures, and listings for safety data from clinical studies
o Participate in development of safety-related data collection forms for clinical studies
o Attend study team meetings as requested or needed
• Conduct signal detection, evaluation, and management
o Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO
• Prepare safety assessment reports and other safety documents and regulatory responses
• Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
• Participates in Safety Governance per Amgen processes
• Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body
• Assist GSOs and other Senior Scientists in the development of risk management strategy and activities
• Provides contents for risk management plans
• 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/ or other Senior Scientist in developing a strategy for safety-related regulatory activities
• Provide safety contents for filings
• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
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
The PV Scientist contributes to GPS in the following ways:
• Contribute to the development, improvement, and standardization of pharmacovigilance processes and methods
• Participates on teams for the implementation of new processes and methods within the Therapeutic Area

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-Beginning knowledge of the following:
• Signal detection, evaluation and management
• Aggregate data analysis
• Good clinical and scientific judgment
• Application of medical concepts and terminology
• Document writing and source document review
• Data interpretation and synthesis
• Basic skills in application of statistical and epidemiological methods to pharmacovigilance
• Ability to convey complex, scientific data in an understandable way
• Ability to analyze and interpret complex safety data
• Beginning skills in writing Risk Management Plans

Biomedical Literature-Beginning 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
• Knowledge of the Pharm/bio industry
• 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 work-flow analysis on processes impacting multiple areas across the organization
• Adapts and integrates own experience with Amgen-wide strategy if applicable
• Develops innovative solutions to problems without precedent
• Works in partnership with GPS team to develop business plans that support the direction of the business

Autonomy
Under the direction of more senior GPS staff, participates in the following:
• Strategy, goals and changes within area of responsibility
• Contributes to strategic decisions affecting the discipline
• Contributes ideas through development into a final product

Education & Experience
(Basic)
Doctorate degree
OR
Master’s degree and 3 years of directly related experience
OR
Bachelor’s degree and 5 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)
BS or BA in Life Science with a MS and 3 years of related experience
OR
Bachelor’s degree and 5 years of related experience
And
Previous managerial experience directly managing people and/or experience leading teams, project, programs or directing the allocation of resources
Clinical/medical research experience
Experience in a biotech/pharmaceutical setting

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