Title: Global Safety Sr Mgr
Duration: 12 Months
Location: Thousand Oaks, CA 91320
 
Top 3 Must Have Skill Sets:

• Direct Pharmacovigilance experience (Not PV operation or safety reporting)
• safety signal assessment and management experience
• Aggregate data review and assessment

 
Description:
The Global PV Sr. Scientist 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.
Applicable tasks may vary by product(s) assigned. The Global PV Sr. Scientist is responsible for the following:

• Directs the planning, preparation, writing and review of portions of aggregate reports
• Organize and direct liaison for activities with affiliates and other internal client’s 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 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
  • 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
• 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 labelling
• 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 skill
• 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 the client

 
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 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

 
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

 
Qualifications

• 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
• BS or BA in Life Science with a MS and 6 years of related experience
  OR
• Bachelor’s degree and 8 years of related experience

And

• 2 years of managerial experience directly managing people and or leadership experience leading teams, project, programs or directing the allocation of resources
• Clinical/medical research experience
• 6 years of experience in a biotech/pharmaceutical setting
• Previous management and/or mentoring experience

 
Day to Day Responsibilities:

• Review daily SAEs
• Assist GSO and other scientist is filing activities, responds to RTQs, daily routine PV activities, and other ad hoc requests

 
Possible Extension:

• No

 
Red Flags:

• No experience in Pharmacovigilance and safety signal management

 
Interview Process:

• 1:1 with hiring manager
• Panel interview with 2 team members

 
  
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 58.78/hr.