Global Safety Senior Manager / Pharmacovigilance Senior Scientist

At Amgen, innovation is more than just a buzzword. It's how we give new options and hope to patients with serious illnesses - from widespread cancers to orphan diseases like acute lymphoblastic leukemia (ALL). We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules - and we need top talent to ensure these molecules become medicines and realize their potential for helping patients. We need collaborative and innovative world-class talent to ensure these molecules become medicines and that they will strive to reach their full potential while helping patients.

The Global Safety Senior Manager/Pharmacovigilance (PV) Senior Scientist works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise as needed to GPS.

Applicable tasks may vary by product(s) assigned. The Global PV Sr. Scientist is responsible for the following:

• Directs the planning, preparation, writing and review of portions of aggregate reports
• Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products
• 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 content for risk management plans
• Develop or update strategy and content for regional risk management plans
• Assist GSO to oversee risk minimization activities including tracking of activities as needed
• Evaluate risk minimization activities
• 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
• 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

Basic Qualifications

Doctorate degree and 2 years of Pharmacovigilance and/or drug/product safety experience
OR
Master's degree and 6 years of Pharmacovigilance and/or drug/product safety experience
OR
Bachelor's degree and 8 years of Pharmacovigilance and/or drug/product safety experience
OR
Associate's degree and 10 years of Pharmacovigilance and/or drug/product safety experience
OR
High school diploma / GED and 12 years of Pharmacovigilance and/or drug/product safety experience

Preferred Qualifications

• BS, RN or PharmD degree
• 4+ years Pharmacovigilance experience in the Pharmaceutical or Biotech industry
• 4+ years benefit risk evaluations, therapeutic area safety in oncology
• Broad PV knowledge with expertise within defined subject area
• Applied knowledge and broad understanding of multiple disciplines
• Experience in signal detection, evaluation, aggregate data analysis, and interpretation
• Experience with document writing and source document review
• Ability to convey complex, scientific data in an understandable way
• Good clinical and scientific judgment
• Knowledge of Application of medical concepts and terminology

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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