Pharmacovigilance Scientist, Senior Manager
US - California - Thousand Oaks - Field/Remote
Career Category
SafetyJob Description
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youâre part of something bigger, itâs because you are. At Amgen, our shared missionâto serve patientsâdrives all that we do. It is key to our becoming one of the worldâs leading biotechnology companies. We are global collaborators who achieve togetherâresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Itâs time for a career you can be proud of.
Pharmacovigilance Scientist, Senior Manager
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What you will do
Letâs do this. Letâs change the world. 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.
In this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations and provide scientific and compliance expertise as needed to GPS.
Responsibilities:
- 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
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 Teamâs 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 with aspects of risk âŠ
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Annual bonus program Career development Career development opportunities Comprehensive employee benefits package Financial plans Flexible Spending Accounts Flexible work models Health and welfare plans Life and Disability insurance Retirement and Savings Plan Stock-based long-term incentives Time-off plans Total Rewards Plan
Tasks- Data Analysis
Biotechnology Clinical Development Clinical trials Collaboration Compliance Data analysis Drug Development Leadership Operations Pharmacovigilance Regulatory filings Risk Management Safety Assessment Sales Statistical analysis plans Strategy Teams Therapeutic Areas
EducationAssociate DO Doctorate Doctorate degree GED High school diploma
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9