Global Pharmacovigilance (PV) Scientist, Senior Manager

About the Role

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
• Support and provide oversight to staff with regards to safety in clinical trials, including:
  • Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
  • Review 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
• Perform signal detection, evaluation, and management, including:
  • Perform data analysis to evaluate safety signals and write up analysis results
  • Document 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, including:
  • Provide 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, including:
  • Assist GSO in developing a strategy for safety-related regulatory activities
  • Provide safety contents for filings
• Undertake inspection readiness 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 industry pharmacovigilance experience OR
• Master's degree and 4 years of industry pharmacovigilance experience OR
• Bachelor's degree and 6 years of industry pharmacovigilance experience OR
• Associate's degree and 10 years of industry pharmacovigilance experience OR
• High school diploma/GED and 12 years of industry pharmacovigilance experience

Preferred Qualifications

• BS in Life Science with 3 years drug safety experience, preferably industry pharmacovigilance experience
• Experience in signal detection, evaluation and management
• Experience of Literature Surveillance: source document review knowledge and skills
• Experience in aggregate data analysis, interpretation and synthesis
• Good clinical and scientific judgment
• Clinical and/or medical research experience
• Understanding of methods of qualitative and quantitative safety data analysis

Pay

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.

Benefits

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.