Senior Manager, Global Pharmacovigilance Safety – Obesity

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversees the planning, preparation, composition, and evaluation of segments of aggregate reports.

• Coordinates and manages communication with affiliates and other internal Amgen partners concerning products.

• Provides support and oversight to personnel regarding safety in clinical trials.

• Reviews and offers input on study protocols, statistical analysis plans, and additional clinical study-related documents.

• Assesses AEs/SAEs from clinical trials as necessary.

• Evaluates standard designs of tables, figures, and listings for safety data derived from clinical studies.

• Engages in the creation of safety-related data collection forms for clinical trials.

• Participates in study team meetings as requested or when necessary.

• Conducts signal detection, evaluation, and management.

• Performs data analyses to assess safety signals and documents the analysis results.

• Records work as required within the safety information management system.

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

• Searches and reviews adverse event data, literature, and other safety-relevant information for signal detection purposes.

• Prepares presentations of the Global Safety Team’s recommendations regarding safety issues for the cross-functional decision-making body.

• Assists the GSO in formulating risk management strategies and activities.

• Provides content for risk management plans.

• Develops or updates strategies and content for regional risk management plans.

• Aids GSOs in supervising risk minimization activities, including tracking as necessary.

• Evaluates risk minimization efforts.

• Prepares responses to regulatory inquiries related to risk management plans under the guidance of the GSO.

• Supports tasks related to new drug applications and other regulatory submissions.

• Assists the GSO in strategizing safety-related regulatory activities.

• Supplies safety content for regulatory filings.

• Ensures Inspection Readiness.

• Undertakes tasks assigned by the QPPV as specified in the PV System Master File.

• Maintains a state of readiness for inspections.

⛳️ Requirements

• Doctorate degree with 2 years of industry pharmacovigilance experience OR Master’s degree with 4 years of industry pharmacovigilance experience OR Bachelor's degree with 6 years of industry pharmacovigilance experience OR Associate’s degree with 10 years of industry pharmacovigilance experience OR High school diploma/GED with 12 years of industry pharmacovigilance experience.

• Bachelor’s degree in life sciences.

• 2 years of experience in a managerial role directly overseeing people or projects and/or mentoring experience.

• Experience in clinical or medical research.

• 6 years of experience within the biotech/pharmaceutical industry.

🏝️ Benefits

• A comprehensive employee benefits package, which includes 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 feasible.