Global Pharmacovigilance Senior Scientist - Nephrology/Inflammation (Open to Remote)

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Amgen is seeking a Global Pharmacovigilance Senior Scientist to join the Nephrology/Inflammation therapeutic area within Global Patient Safety & Pediatrics.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.

The Global PV Sr. Scientist works with the Therapeutic Safety Teams on aggregate safety assessment activities. This person will also provide scientific and compliance expertise as needed to GPS.

KEY RESPONSIBILITIES

Applicable tasks may vary by product(s) assigned. The Global PV Sr. Scientist is responsible for the following:

• 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 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

BASIC QUALIFICATIONS

Doctorate degree and 2 years of directly related experience
OR
Masters degree and 6 years of directly related experience
OR
Bachelors degree and 8 years of directly related experience
OR
Associates degree and 10 years of directly related experience
OR
High school diploma / GED and 12 years of directly related experience

PREFERRED QUALIFICATIONS

PharmD, NP, or PA with 4 years of Global Pharmacovigilance Scientist experience

OR

BSN and 6 years of Global Pharmacovigilance Scientist experience

Clinical experience is a plus.

PREFERRED SKILLS

• Aggregate data analysis, interpretation and synthesis in clinical development and post-market settings

• Signal detection, signal management, and safety governance

• Methods of qualitative and quantitative safety data analysis

• Processes and regulations for pharmacovigilance, risk management, and risk minimization

• Drug development and lifecycle management

• Argus

• MedDRA

• Product and disease state knowledge

• 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

• Ability to analyze, interpret, and convey complex, scientific data

• Application of statistical and epidemiological methods to pharmacovigilance

• Strong written, presentation, verbal communications skills, including medical/scientific writing

• Organization, prioritization, planning skills and ability to collaborate, problem-solve, adapt, and work effectively within a matrix environment

• Computer skills (e.g., MS Office Suite and safety systems)

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.