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Global Safety Senior Manager (Pharmacovigilance Senior Scientist) United Kingdom,  

Amgen (company)

Posted on : 22 October 2017

Project Description

Global Safety Senior Manager (Pharmacovigilance Senior Scientist)

Uxbridge OR Cambridge

Competitive salary & comprehensive benefits package including bonus scheme

The company:
Amgen is one of the world s largest independent biotechnology companies, with global revenue in excess of $18 billion and over 18,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.

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 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.

Key Activities:
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 Amgen 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 filingsAssist 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 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 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

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 Requirements:

University degree in Life Sciences
Extensive industry experience in a related role
Managerial experience directly managing people and or leadership experience leading teams, project, programs or directing the allocation of resources
Clinical/medical research experience
Strong experience in a biotech/pharmaceutical setting
Previous management and/or mentoring experience

Amgen is an equal opportunity employer.


United Kingdom, Uxbridge; United Kingdom, Cambridgeshire

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