Global Pharmacovigilance (PV) Scientist, Manager- Oncology
Amgen
Summary
In this vital role, you will partner closely with Global Safety Officers (GSOs), Clinical Development, Regulatory Affairs, and other cross-functional stakeholders to develop and execute product safety strategies across the product lifecycle, from early development through post-marketing phases. The Immuno-Oncology team supports an exciting portfolio spanning investigational and marketed products, requiring innovative and collaborative safety leadership to ensure patients have access to safe and effective therapies.
Job description
Product Safety Surveillance & Signal Management
- 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.
Aggregate Safety Reporting & Safety Assessments
- 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, and 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.
Clinical Development Support
- 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.
Safety Governance & Cross-Functional Leadership
- 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.
Risk Management
- Contribute to the development and execution of global risk management strategies throughout the product lifecycle.
- Develop and maintain safety content for Risk Management Plans (RMPs), risk minimization activities, and related regulatory documentation.
- Support implementation and tracking of risk minimization measures.
- Evaluate effectiveness of risk minimization activities and recommend enhancements as appropriate.
- Support responses to regulatory inquiries related to risk management activities.
Regulatory Support
- Provide strategic safety support for regulatory submissions, health authority interactions, product launches, and lifecycle management initiatives.
- Partner with GSOs in developing and executing global safety regulatory strategies.
- Prepare safety content and supporting documentation for regulatory filings and submissions.
- Support preparation of responses to regulatory authority questions and requests.
Compliance & Inspection Readiness
- Support regulatory inspections, audits, and pharmacovigilance compliance activities while maintaining a continuous state of inspection readiness.
- Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as described within the Pharmacovigilance System Master File.
- Ensure compliance with global pharmacovigilance regulations, GVP guidance, ICH requirements, and internal Amgen procedures.
Process Improvement & Scientific Leadership
- Lead or support initiatives that improve pharmacovigilance processes, methodologies, quality, compliance, and operational efficiency.
- Participate on teams responsible for implementation of new safety processes, technologies, and methodologies.
- Provide scientific leadership and mentorship to junior pharmacovigilance scientists and project team members.
- Contribute to safety strategy discussions supporting oncology, immunology, inflammation, rare disease, and biologic development programs.
- Perform other duties related to the position as assigned by management or described in applicable procedures.
Requirements
- Doctorate degree OR Master’s degree and 2 years of Industry Pharmacovigilance experience OR Bachelor’s degree and 4 years of Industry Pharmacovigilance experience OR Associate’s degree and 8 years of Industry Pharmacovigilance experience OR High school diploma / GED and 10 years of Industry Pharmacovigilance experience
- Advanced scientific or healthcare degree preferred (PharmD, PhD, RN, NP, PA, MD, or equivalent scientific discipline)
- 5+ years of pharmacovigilance or drug safety experience within biotechnology, pharmaceutical, or CRO environments
- Demonstrated experience in signal detection, signal evaluation, signal analysis, and signal management activities
- Experience authoring and/or reviewing aggregate safety reports including PBRERs, PSURs, DSURs, and Safety Assessment Reports
- Experience supporting benefit-risk assessments for investigational and/or marketed products
- Experience developing, maintaining, or supporting Risk Management Plans (RMPs), REMS, or other risk minimization strategies
- Experience utilizing literature surveillance and external data sources to support signal detection and safety assessments
- Experience using Argus Safety and/or other global safety databases and signal management tools
- Knowledge of FDA, EMA, ICH, and global pharmacovigilance regulations and guidance
- Experience supporting regulatory submissions, inspections, audits, and health authority responses
- Clinical development, medical affairs, clinical research, and/or pharmacovigilance experience supporting products in both development and post-marketing settings
- Experience within oncology, immunology, inflammation, rare disease, biologics, or related therapeutic areas preferred
- Demonstrated clinical and scientific judgment with the ability to interpret complex safety data and communicate risk effectively
- Proven ability to influence and lead within a highly matrixed, cross-functional environment
- Experience presenting safety assessments and recommendations to governance committees and senior leadership
- Excellent written, verbal, presentation, and stakeholder management skills
Benefits
- Retirement and Savings Plan
- Medical, Dental & Vision
- Life and Disability Insurance
- Flexible Spending Accounts
- Discretionary Annual Bonus
- Stock-based Long-term Incentives
- Time-off Plans
- Flexible Work Models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.