Job Information
Amgen Pharmacovigilance Scientist, Senior Manager in Washington D.C., District Of Columbia
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Pharmacovigilance Scientist, Senior Manager
Live
What you will do
Let’s do this. Let’s 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 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 with aspects of 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
Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labeling
Pharmacovigilance skills-intermediate knowledge of the following:
Signal detection, evaluation and management
Aggregate data analysis, interpretation and synthesis
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
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek has these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of safety/ pharmacovigilance related experience
Or
Master’s degree and 6 years of safety/ pharmacovigilance related experience
Or
Bachelor’s degree and 8 years of safety/ pharmacovigilance related experience
Or
Associate’s degree and 10 years of safety/ pharmacovigilance related experience
Or
High school diploma / GED and 12 years of safety/ pharmacovigilance 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
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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