Global Safety Manager

Amgen • Washington, DC

84d • Hybrid

About The Position

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.

Requirements

• Doctorate degree OR Master's degree and 2 years of relevant experience OR Bachelor's degree and 4 years of relevant experience.

Nice To Haves

• Healthcare professional background.
• 1 year of drug safety/PV experience.
• Experience in signal detection, evaluation and management.
• Experience as a contributor to periodic aggregate safety reports.
• Experience with literature surveillance: source document review, knowledge, and skills.
• Experience with the Argus Safety database.
• Good clinical and scientific judgment.
• Clinical and/or medical research experience.
• Strong written and verbal communication skills.

Responsibilities

• Contributes to the planning, preparation, writing and review of periodic aggregate safety reports.
• Works with affiliates and other internal Amgen partners regarding deliverables.
• Review of adverse events and serious adverse events from clinical trials.
• Contributes under the direction of the Global PV Sr. Scientist or Lead.
• Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents.
• 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.
• Attend study team meetings as requested or needed.
• Conduct signal detection, evaluation, and management.
• Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO.
• Prepare safety assessment reports and other safety documents and regulatory responses.
• Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection.
• Participates in Safety Governance per Amgen processes.
• Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional decision-making body.
• Assist GSOs and other Senior Scientists in the development of risk management strategy and activities.
• Provides contents for risk management plans.
• 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/ or other Senior Scientist in developing a strategy for safety-related regulatory activities.
• Provide safety contents for filings.
• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by the supervisor.

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, and 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, including remote and hybrid work arrangements, where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree