184 applicants

Company

Original Job Post

Amgen · 2 days ago

Global Pharmacovigilance (PV) Senior Scientist, Obesity

United States

Full-time

Hybrid

Senior Level

$143K/yr - $168K/yr

4+ years exp

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Comp. & Benefits

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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

Support and provide 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

Qualification

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PharmacovigilanceSafetyObesity therapeutic areaClinical studiesLarge data sets

Required

Doctorate degree and 2 years of safety/ pharmacovigilance experience

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

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

Associate degree and 10 safety/ pharmacovigilance experience

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

Preferred

Experience in Obesity therapeutic area

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

Benefits

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