Global Pharmacovigilance Safety, Senior Manager- Obesity

Amgen • Newark, NJ

6h

About The Position

The Global Pharmacovigilance Senior Manager works with Therapeutic Safety Teams on safety assessment activities for medical and scientific operations. The role directs the planning, preparation, writing, and review of portions of aggregate reports; coordinates activities with affiliates and internal Amgen partners; and supports staff and clinical-trial safety oversight. Responsibilities also include signal detection and evaluation, preparing safety assessments and regulatory responses, supporting risk-management strategy and activities, assisting with regulatory filings, and maintaining inspection readiness.

Requirements

• One of the following education and industry pharmacovigilance experience combinations: doctorate degree and 2 years; master’s degree and 4 years; bachelor’s degree and 6 years; associate’s degree and 10 years; or high school diploma/GED and 12 years.

Nice To Haves

• Bachelor’s degree in life science and a master’s degree, with 6 years of related experience.
• 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.

Responsibilities

• Direct planning, preparation, writing, and review of portions of aggregate reports.
• Organize and direct liaison activities with affiliates and other internal Amgen partners regarding products.
• Support and provide oversight to staff on clinical-trial safety activities.
• Review and provide input on study protocols, statistical analysis plans, and other clinical study-related documents.
• Review adverse events and serious adverse events from clinical trials as needed.
• Review standard designs of tables, figures, and listings for safety data from clinical studies.
• Participate in developing 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 document analysis results.
• Document 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 signal detection.
• Prepare presentations of the Global Safety Team’s recommendations on safety issues for cross-functional decision-making bodies.
• Assist the GSO with risk-management strategy and activities, including providing content for risk-management plans and developing or updating regional risk-management plans.
• Assist GSOs in overseeing and tracking risk-minimization activities, and evaluate those activities.
• Prepare responses to regulatory inquiries related to risk-management plans under GSO guidance.
• Support safety-related regulatory activities and provide safety content for new drug applications and other regulatory filings.
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain inspection readiness.
• Represent the function and serve as a point of contact for Health Authority inspections and internal process audits within the remit of the role.

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.
• Flexible spending accounts.
• Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.
• Career development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed