Global Pharmacovigilance; PV) Scientist, Manager- Oncology

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

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.

Let’s do this. Let’s change the world.

The Global Pharmacovigilance Manager is responsible for the following:

• Lead signal detection, validation, prioritization, evaluation, and management activities utilizing multiple safety data sources and signal detection methodologies.
• Conduct scientific and medical evaluation of adverse events and emerging safety concerns from clinical trials, post-marketing surveillance, literature, and external data sources.
• Perform complex safety analyses and communicate evidence-based recommendations supporting product safety decisions.
• Integrate information from safety databases, clinical studies, literature, epidemiology, and external sources to assess potential safety signals.
• Support and contribute to benefit-risk evaluations that inform product development, regulatory submissions, labeling updates, and lifecycle management decisions.
• Collaborate with GSOs to evaluate safety concerns and recommend appropriate risk mitigation strategies.

• Lead or contribute to the planning, preparation, authoring, review, and submission of aggregate safety reports, including:
  • PBRERs/PSURs
  • DSURs
  • Safety Assessment Reports
  • Regulatory safety responses
  • Other global pharmacovigilance deliverables
• Prepare clear, scientifically sound analyses and conclusions regarding product safety profiles.
• Ensure the quality, consistency, and scientific integrity of safety assessments and aggregate reports.

• Provide strategic safety input into clinical protocols, statistical analysis plans, safety analysis plans, investigator brochures, and clinical study reports.
• Review and provide recommendations regarding safety data presentations, including tables, figures, and listings.
• Participate on study teams and collaborate with Clinical Development partners to support ongoing safety surveillance activities.
• Contribute to development of safety-related data collection tools and methodologies for clinical studies.

• Represent Global Patient Safety within safety governance and cross-functional teams.
• Present safety analyses, emerging signals, benefit-risk assessments, and Global Safety Team recommendations to governance committees and cross-functional decision-making bodies.
• Collaborate effectively with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, Epidemiology, and other key stakeholders.
• Influence strategic safety decisions through effective communication and scientific leadership.

• Con…