Global Pharmacovigilance (PV) Senior Scientist, Obesity, US - Remote

Key responsibilities:

• Support and provide oversight with regards to safety in clinical trials by providing inputs on study protocols, statistical analysis plan, other study related documents and review of safety data from clinical studies

• Direct the planning, preparation, writing and review of portions of aggregate reports

• Organize and direct liaison for activities with affiliates and other internal Amgen partners regarding products

• Supports and provides 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 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 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

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Safety professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of safety/ pharmacovigilance experience

OR

Master's degree and 4 years of safety/ pharmacovigilance experience

OR

Bachelor's degree and 6 years of safety/ pharmacovigilance experience

OR

Associate degree and 10 safety/ pharmacovigilance experience

OR

High school diploma / GED and 12 years of safety/ pharmacovigilance experience

Preferred Qualifications:

• Experience in Obesity therapeutic area

• Experience in clinical studies with large number of participants and data sets

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 $142,859.00 to $168,300.00. 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 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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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.

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.

#obesity

Salary Range
142,859.00 USD - 168,300.00 USD