Global Pharmacovigilance Senior Scientist

This is a fully remote position, open to applicants in Kentucky, +2 more states.

📋 Description

• Oversee the planning, preparation, writing, and review of sections of aggregate reports.

• Coordinate and manage interactions with affiliates and other internal Amgen partners regarding products.

• Author Safety Assessment Reports and other safety documentation, as well as regulatory responses in collaboration with the GSO.

• Evaluate and provide feedback on study protocols, statistical analysis plans, and other documents related to clinical studies.

• Review adverse events (AEs) and serious adverse events (SAEs) from clinical trials as necessary.

• Assess the standard design of tables, figures, and listings for safety data derived from clinical studies.

• Contribute to the development of safety-related data collection forms for clinical studies.

• Attend study team meetings as required or upon request.

• Conduct data analysis to assess safety signals and document the results of the analysis.

• Investigate and evaluate adverse event data, literature, and other safety-related information for signal detection purposes.

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

• Support the GSO in formulating risk management strategies and activities, including providing content for risk management plans.

• Create or revise the strategy and content for regional risk management plans.

• Assist GSOs in supervising risk minimization efforts, including tracking necessary activities.

• Assess risk minimization activities.

• Prepare responses to regulatory inquiries concerning risk management plans under the guidance of the GSO.

• Facilitate activities linked to new drug applications and other regulatory submissions.

• Aid the GSO in crafting a strategy for safety-related regulatory activities.

• Supply safety-related content for regulatory filings.

• Execute tasks assigned by the QPPV as outlined in the PV System Master File and maintain readiness for inspections.

• Serve as the representative and point of contact for Health Authority Inspections and Internal Process Audits within the scope of the role and responsibilities.

⛳️ Requirements

• Doctorate degree with 2 years of relevant experience, or a Master's degree with 4 years of related experience, or a Bachelor's degree with 6 years of relevant experience, or an Associate’s degree with 10 years of related experience, or a High school diploma/GED with 12 years of related experience.

• BS or BA in Life Science along with a MS and 6 years of relevant experience.

• At least 2 years of managerial experience directly supervising personnel or leadership experience in leading teams, projects, programs, or directing resource allocation.

• Experience in clinical or medical research.

• A minimum of 6 years of experience in a biotech or pharmaceutical environment.

• Previous management and/or mentoring experience is preferred.

🏝️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous contributions from the company.

• 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.