Global Pharmacovigilance (PV) Senior Scientist

Let’s do this. Let’s change the world. In this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations.

Responsibilities:

• 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

• Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO

• 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

• 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

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

Basic Qualifications:

Doctorate degree and 2 years of related experience

OR

Master’s degree and 4 years of related experience

OR

Bachelor’s degree and 6 years of related experience

OR

Associate’s degree and 10 years of related experience

OR

High school diploma / GED and 12 years of related experience

Preferred Qualifications:

• BS or BA in Life Science with a MS and 6 years of related experience

• Bachelor’s degree and 8 years of related experience

• 2 years of managerial experience directly managing people and or leadership experience leading teams, project, programs or directing the allocation of resources

• Clinical/medical research experience

• 6 years of experience in a biotech/pharmaceutical setting

• Previous management and/or mentoring experience

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, we’ll 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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.

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.

Sponsorship for this role is not guaranteed.

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Salary Range