Global Safety Manager

Role Summary

Global Safety Manager — Join Amgen’s mission to serve patients and contribute to safety leadership across immuno-oncology products from development through post-marketing. Collaborate with Global Safety Officers and PV scientists to deliver safety strategy and major safety deliverables.

Responsibilities

• Contributes to planning, preparation, writing and review of periodic aggregate safety reports.
• Works with affiliates and internal partners regarding deliverables.
• Reviews adverse events and serious adverse events from clinical trials.
• Contributes under the direction of the Global PV Senior Scientist or Lead.
• Reviews input on study protocols, statistical analysis plans and other clinical-study documents.
• Reviews design of safety data tables, figures, and listings from clinical studies.
• Participates in development of safety-related data collection forms for clinical studies.
• Attends study team meetings as requested.
• Conducts signal detection, evaluation, and management.
• Performs data analysis to evaluate safety signals and writes up results with GSO.
• Prepares safety assessment reports and regulatory responses.
• Reviews safety-relevant data for signal detection.
• Participates in Safety Governance per Amgen processes.
• Prepares presentations of safety recommendations to cross-functional bodies.
• Assists GSOs and senior scientists in risk management strategy and activities.
• Provides contents for risk management plans and updates regional plans.
• Oversees risk minimization activities and evaluates their effectiveness.
• Prepares responses to regulatory inquiries related to risk management plans.
• Supports regulatory filings related to safety.
• Assists in developing strategies for safety-related regulatory activities and provides safety contents for filings.
• Performs other duties as defined in SOPs or by supervisor.

Qualifications

• Basic Qualifications: Doctorate degree; or Master‚Äôs degree with 2 years of relevant experience; or Bachelor‚Äôs degree with 4 years of relevant experience.
• Preferred Qualifications: Healthcare professional background; 1 year of drug safety/PV experience; experience in signal detection, evaluation and management; experience contributing to periodic aggregate safety reports; experience with literature surveillance; experience with the Argus Safety database; good clinical and scientific judgment; clinical/medical research experience; strong written and verbal communication skills.

Skills

• Signal detection and safety data analysis
• Regulatory reporting and risk management planning
• Cross-functional collaboration and scientific communication