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Amgen

#WeareBiotech

Senior Manager, Global Pharmacovigilance Safety – Obesity

ManagerManagerFull TimeRemoteSeniorTeam 10,001+Since 1980H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

4 days ago

Salary

$140.8K - $190.5K / year

Seniority

Senior

Postgraduate Degree2 yrs expEnglish

Job Description

Senior Manager, Global Pharmacovigilance Safety – Obesity

Amgen

• 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 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 • Maintain a state of inspection readiness.

Job Requirements

  • 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
  • Bachelor’s in life science
  • 2 years of managerial experience directly managing people or projects and/or mentoring experience
  • Clinical or medical research experience
  • 6 years of experience in the biotech/pharmaceutical setting

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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