Global Pharmacovigilance (PV) Senior Scientist
About the position
Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas - Oncology, Inflammation, General Medicine, and Rare Disease - we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives. Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Responsibilities
• Direct the planning, preparation, writing and review of portions of aggregate reports.
• Organize and direct liaison for activities with affiliates and other internal Amgen partners regarding products.
• Support and provide oversight to staff with regards to safety in clinical trials to review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents.
• Review of AE/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.
• Perform data analysis to evaluate safety signals and write up analysis results.
• Author safety assessment reports and other safety documents and regulatory responses in collaboration with the Global Safety Officer (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 GSOs in the development of risk management strategy and activities.
• Provide contents for risk management plans.
• Develop or update strategy and content for regional risk management plans.
• Assist GSOs to oversee risk minimization activities including tracking of activities as needed.
• Evaluate risk minimization activity.
• 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.
Requirements
• Doctorate degree and 2 years of pharmacovigilance experience.
• Master's degree and 6 years of pharmacovigilance experience.
• Bachelor's degree and 8 years of pharmacovigilance experience.
• Associate's degree and 10 years of pharmacovigilance experience.
• High school diploma / GED and 12 years of pharmacovigilance experience.
Nice-to-haves
• BS or BA in Life Science with a MS and 6 years of related experience.
• Bachelor's degree and 8 years of related experience.
• 2 years of managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.
• Clinical/medical research experience.
• 6 years of experience in a biotech/pharmaceutical setting.
• Previous management and/or mentoring experience.
Benefits
• A 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.
• A discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements.
Apply Now
Apply Now
Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas - Oncology, Inflammation, General Medicine, and Rare Disease - we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives. Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Responsibilities
• Direct the planning, preparation, writing and review of portions of aggregate reports.
• Organize and direct liaison for activities with affiliates and other internal Amgen partners regarding products.
• Support and provide oversight to staff with regards to safety in clinical trials to review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents.
• Review of AE/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.
• Perform data analysis to evaluate safety signals and write up analysis results.
• Author safety assessment reports and other safety documents and regulatory responses in collaboration with the Global Safety Officer (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 GSOs in the development of risk management strategy and activities.
• Provide contents for risk management plans.
• Develop or update strategy and content for regional risk management plans.
• Assist GSOs to oversee risk minimization activities including tracking of activities as needed.
• Evaluate risk minimization activity.
• 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.
Requirements
• Doctorate degree and 2 years of pharmacovigilance experience.
• Master's degree and 6 years of pharmacovigilance experience.
• Bachelor's degree and 8 years of pharmacovigilance experience.
• Associate's degree and 10 years of pharmacovigilance experience.
• High school diploma / GED and 12 years of pharmacovigilance experience.
Nice-to-haves
• BS or BA in Life Science with a MS and 6 years of related experience.
• Bachelor's degree and 8 years of related experience.
• 2 years of managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.
• Clinical/medical research experience.
• 6 years of experience in a biotech/pharmaceutical setting.
• Previous management and/or mentoring experience.
Benefits
• A 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.
• A discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements.
Apply Now
Apply Now