Global Pharmacovigilance (PV) Scientist Lead

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.

Key Activities

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

Management Responsibilities

• 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

Basic Qualifications:

Doctorate degree and 4 years of directly related experience

OR

Master's degree and 8 years of directly related experience

OR

Bachelor's degree and 10 years of directly related experience

AND

6 years of managerial experience directly managing people and/or leadership experience leading teams,

projects, programs or directing the allocation of resources

Preferred Qualifications:

MS in life sciences and 8 years of directly related experience

OR

Bachelor's degree and 10 years of directly related experience

AND

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

potential.

Join Us

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.

Join Us

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.