Global Pharmacovigilance Scientist, Manager – Oncology

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate closely with Global Safety Officers, Clinical Development, Regulatory Affairs, and various cross-functional stakeholders to formulate and implement product safety strategies throughout the product lifecycle.

• Oversee signal detection, validation, prioritization, evaluation, and management utilizing multiple safety data sources and methodologies.

• Conduct scientific and medical assessments of adverse events and emerging safety issues arising from clinical trials, post-marketing surveillance, literature, and external data sources.

• Execute intricate safety analyses and convey evidence-based recommendations that support product safety decisions.

• Integrate safety databases, clinical studies, literature, epidemiology, and external sources to evaluate potential safety signals.

• Assist in benefit-risk evaluations that guide product development, regulatory submissions, labeling updates, and lifecycle management.

• Lead or contribute to the planning, preparation, authoring, review, and submission of aggregate safety reports, including PBRERs/PSURs, DSURs, Safety Assessment Reports, and regulatory safety responses.

• Provide strategic safety insights into clinical protocols, statistical analysis plans, safety analysis plans, investigator brochures, and clinical study reports.

• Review and suggest enhancements to safety data presentations, including tables, figures, and listings.

• Represent Global Patient Safety in safety governance and cross-functional teams.

• Present safety analyses, emerging signals, benefit-risk assessments, and Global Safety Team recommendations to governance committees and decision-making bodies.

• Contribute to global risk management strategies, Risk Management Plans, risk minimization initiatives, and regulatory documentation.

• Support regulatory submissions, health authority interactions, product launches, and lifecycle management efforts.

• Assist with regulatory inspections, audits, pharmacovigilance compliance activities, and maintaining continuous inspection readiness.

• Undertake tasks as delegated by the Qualified Person for Pharmacovigilance as outlined in the Pharmacovigilance System Master File.

• Ensure adherence to global pharmacovigilance regulations, GVP guidelines, ICH requirements, and internal Amgen procedures.

• Lead or assist in initiatives aimed at enhancing pharmacovigilance processes, methodologies, quality, compliance, and operational efficiency.

• Participate in the implementation of new safety processes, technologies, and methodologies.

• Provide scientific leadership and mentorship to junior pharmacovigilance scientists and project team members.

• Engage in safety strategy discussions that support oncology, immunology, inflammation, rare disease, and biologic development programs.

• Perform additional duties related to the position as assigned by management or described in relevant procedures.

⛳️ Requirements

• Doctorate degree OR Master’s degree with 2 years of Industry Pharmacovigilance experience OR Bachelor’s degree with 4 years of Industry Pharmacovigilance experience OR Associate’s degree with 8 years of Industry Pharmacovigilance experience OR High school diploma / GED with 10 years of Industry Pharmacovigilance experience.

• Advanced scientific or healthcare degree is preferred (PharmD, PhD, RN, NP, PA, MD, or equivalent scientific discipline).

• At least 5 years of pharmacovigilance or drug safety experience in biotechnology, pharmaceutical, or CRO environments.

• Proven experience in signal detection, signal evaluation, signal analysis, and signal management activities.

• Experience in authoring and/or reviewing aggregate safety reports including PBRERs, PSURs, DSURs, and Safety Assessment Reports.

• Background in supporting benefit-risk assessments for investigational and/or marketed products.

• Experience in developing, maintaining, or supporting Risk Management Plans (RMPs), REMS, or other risk mitigation strategies.

• Familiarity with literature surveillance and external data sources for signal detection and safety assessments.

• Proficient in 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 in supporting regulatory submissions, inspections, audits, and health authority responses.

• Clinical development, medical affairs, clinical research, and/or pharmacovigilance experience in both development and post-marketing settings.

• Experience in oncology, immunology, inflammation, rare disease, biologics, or related therapeutic areas is preferred.

• Demonstrated clinical and scientific judgment with the capacity 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.

• Sponsorship for this role is not guaranteed.

🏝️ 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 where feasible.

• Financial plans that provide opportunities to save for retirement or other goals.

• Career development opportunities.

• Reasonable accommodations to facilitate participation in the job application or interview process, perform essential job functions, and receive other employment benefits and privileges.