Global Pharmacovigilance Safety, Senior Manager- Obesity

Amgen • Newark, NJ

1d • $140,799 - $190,493

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 aggregate-report planning, preparation, writing, and review; coordinates with affiliates and internal Amgen partners; and supports oversight of safety activities in clinical trials. It also evaluates and manages safety signals, prepares safety assessment and regulatory documents, contributes to risk-management strategies and activities, and supports regulatory filings and inspection readiness. The position may represent the function as a point of contact for Health Authority inspections and internal process audits within its remit.

Requirements

• Doctorate degree and 2 years of industry pharmacovigilance experience; or master’s degree and 4 years; or bachelor’s degree and 6 years; or associate’s degree and 10 years; or high school diploma/GED and 12 years.
• Experience in industry pharmacovigilance at the level specified for the applicable education pathway.

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 the planning, preparation, writing, and review of portions of aggregate reports.
• Organize and direct liaison activities with affiliates and internal Amgen partners regarding products.
• Support and provide oversight to staff on clinical-trial safety activities, including reviewing and providing input on study protocols, statistical analysis plans, and other clinical-study documents.
• Review adverse events and serious adverse events from clinical trials as needed.
• Review standard designs of tables, figures, and listings for clinical-study safety data.
• Participate in developing safety-related data-collection forms for clinical studies and attend study-team meetings as requested or needed.
• Perform data analysis for signal detection, evaluation, and management, and document analysis results.
• Document work in the safety information management system as required.
• 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.
• Present Global Safety Team recommendations on safety issues to 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 plan strategy and content.
• 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 new drug applications and other regulatory filings by assisting with safety-related regulatory strategy and providing safety content.
• Undertake activities delegated by the QPPV as described in the PV System Master File and maintain inspection readiness.
• Serve as a representative and point of contact for Health Authority inspections and internal process audits within the role’s remit and responsibilities.

Benefits

• Health and welfare plans for staff and eligible dependents.
• 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.
• Work/life balance and career development opportunities, which may include flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree