Amgen Global Pharmacovigilance (PV) Scientist Lead in Thousand Oaks, California
Amgen is seeking a Global Pharmacovigilance (PV) Scientist Lead to join our team either in our Thousand Oaks, CA or Camrbidge, Massachusetts campus. Remote options may be also considered for the right candidate.
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.
The Global PV Scientist Lead works with the Therapeutic Safety Head to set direction and strategy for safety assessment activities for the medical/scientific operations with responsibility for providing process insight globally for all products.
This person is accountable for the staff management of the PV Scientists in the therapeutic area and resource planning. Additionally, the incumbent also serves to support the GSO as a safety expert to work on the safety deliverables.
The PV Scientist Lead works closely with the Therapeutic Area Head (TAH) as well as functional heads to implement new and revised processes and pharmacovigilance standards across GPS. This person will also provide scientific and compliance expertise as needed to GPS.
Provides oversight and is an expert advisor to junior PV Scientists to ensure the following activities are performed according to Amgen SOPs across all therapeutic teams.
Applicable tasks may vary by product(s) assigned. The PV Scientist Lead is responsible for overseeing more junior scientists in the following activities and /or may be responsible for the following tasks themselves:
Directs the planning, preparation, writing and review of aggregate reports
Organizes and directs liaison activities with affiliates and other internal Amgen partner regarding products as needed.
Supports and provides oversight to staff with regards to safety in clinical trials including review of SAEs/AEs as needed
Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
Review standard design of tables, figures, and listings for safety data from clinical studies
Perform activities relating to signal detection, evaluation, and management including data analysis to evaluate safety signals and authoring safety assessment reports
Assist GSO in the development of risk management strategy and activities, including providing contents for RMPs)
Participate in activities related to new drug applications and other regulatory filings
The PV Scientist Lead provides strategy and leadership to the Safety Therapeutic Team:
Contribute to the development, improvement, and standardization of pharmacovigilance processes and methods
Lead the implementation of new processes and methods within and across the Therapeutic Areas
Provide training, coaching, mentoring, and development of staff
Assist the leadership team to build an organization and processes that will support future department, company, and industry changes
Knowledge and Skills
Processes and regulations for pharmacovigilance and risk management
Drug development and lifecycle management
Safety database structure and conventions
MedDRA and other dictionaries used in pharmacovigilance
Methods of qualitative and quantitative safety data analysis
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
Pharmacovigilance skills-Advanced Skills
Signal detection, evaluation and management
Aggregate data analysis
Sound clinical and scientific judgment
Application of medical concepts and terminology
Advance skills writing Risk Management plans
Data interpretation and synthesis
Ability to convey complex, scientific data in an understandable way
Ability to analyze and interpret complex safety data
Advanced skills in application of statistical and epidemiological methods to pharmacovigilance
Other skills-Advance skills in the following
Advanced 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
Written and verbal communications skills, including medical/scientific writing
Team leadership and mentoring in a cross-functional, matrix environment
Doctorate degree and 4 years of directly related experience
Master’s degree and 8 years of directly related experience
Bachelor’s degree and 10 years of directly related experience
6 years of managerial experience directly managing people and/or leadership experience leading teams,
projects, programs or directing the allocation of resources
MS in life sciences and 8 years of directly related experience
Bachelor’s degree and 10 years of directly related experience
4 years of managerial experience directly managing people and/or leadership experience leading teams,
projects programs or directing the allocation of resources.
Clinical/medical research experience
6 plus years of product safety experience in a biotech/pharmaceutical setting
Previous management and/or mentoring experience
Amgen provides a collaborative and creative culture in a company with a strong track record of
innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and
we help ensure our staff are equipped to excel today and tomorrow.
Amgen focuses on areas of high unmet medical needs and leverages its expertise to strive for solutions
that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since
1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has
reached millions of patients around the world and is developing a pipeline of medicines with breakaway
If you're seeking a career where you can truly make a difference in the lives of others, a career where
you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, or disability status.