Global Safety Senior Scientist
Company: Amgen
Location: Washington
Posted on: July 18, 2025
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Job Description:
Join Amgens Mission of Serving Patients At Amgen, if you feel
like youre part of something bigger, its because you are. Our
shared missionto serve patients living with serious illnessesdrives
all that we do. Since 1980, weve helped pioneer the world of
biotech in our fight against the worlds toughest diseases. With our
focus on four therapeutic areas Oncology, Inflammation, General
Medicine, and Rare Disease we reach millions of patients each year.
As a member of the Amgen team, youll help make a lasting impact on
the lives of patients as we research, manufacture, and deliver
innovative medicines to help people live longer, fuller happier
lives. Our award-winning culture is collaborative, innovative, and
science based. If you have a passion for challenges and the
opportunities that lay within them, youll thrive as part of the
Amgen team. Join us and transform the lives of patients while
transforming your career. Global Safety Senior Scientist What you
will do Lets do this. Lets change the world. In this vital role 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. The Global PV Sr. Scientist is responsible for
the following: Applicable tasks may vary by product(s) assigned.
Direct 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
Support and provide 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 Teams 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
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 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 experience Or Masters degree and 4
years of safety experience Or Bachelors degree and 6 years of
safety experience Or Associates degree and 10 years of safety
experience Or High school diploma / GED and 12 years of safety
experience Preferred Qualifications: 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 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
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 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 What you can expect of us As we work to
develop treatments that take care of others, we also work to care
for your professional and personal growth and well-being. From our
competitive benefits to our collaborative culture, well support
your journey every step of the way. 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. In
addition to the base salary, Amgen offers a Total Rewards Plan,
based on eligibility, comprising of 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 that may include: A 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
Flexible work models, including remote and hybrid work
arrangements, where possible Apply now and make a lasting impact
with the Amgen team. careers.amgen.com In any materials you submit,
you may redact or remove age-identifying information such as age,
date of birth, or dates of school attendance or graduation. You
will not be penalized for redacting or removing this information.
Application deadline Amgen does not have an application deadline
for this position; we will continue accepting applications until we
receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for
people around the world, Amgen fosters an inclusive environment of
diverse, ethical, committed and highly accomplished people who
respect each other and live the Amgen values to continue advancing
science to serve patients. Together, we compete in the fight
against serious disease. Amgen is an Equal Opportunity employer and
will consider all qualified applicants for employment without
regard to race, color, religion, sex, sexual orientation, gender
identity, national origin, protected veteran status, disability
status, or any other basis protected by applicable law. 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.
Keywords: Amgen, Sterling , Global Safety Senior Scientist, Science, Research & Development , Washington, Virginia
