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Amgen

#WeareBiotech

Global Pharmacovigilance Senior Scientist

ScientistGeneralFull TimeRemoteSeniorTeam 10,001+Since 1980H1B SponsorCompany SiteLinkedIn

Location

Kentucky + 2 moreAll locations: Kentucky | Texas | Wyoming

Posted

14 hours ago

Salary

$140.8K - $190.5K / year

Seniority

Senior

Postgraduate Degree2 yrs expExperience acceptedEnglish

Job Description

Global Pharmacovigilance Senior Scientist

Amgen

• 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 • 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 • Perform data analysis to evaluate safety signals and write up analysis results • 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 • 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

Job Requirements

  • 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
  • BS or BA in Life Science with a MS and 6 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.

Benefits

  • 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
  • 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.

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