Global PV Sr. Scientist

As a Global PV Sr. Scientist at Amgen, you will play a crucial role in collaborating with the Therapeutic Safety Teams on safety assessment activities related to medical and scientific operations. Your responsibilities will include directing the planning, preparation, writing, and review of portions of aggregate reports. Additionally, you will provide oversight to staff on safety in clinical trials, review study protocols, statistical analysis plans, clinical study-related documents, adverse events, and safety data from clinical studies. Key Responsibilities: - Collaborate with Therapeutic Safety Teams on safety assessment activities - Direct the planning, preparation, writing, and review of portions of aggregate reports - Provide oversight to staff on safety in clinical trials - Review study protocols, statistical analysis plans, clinical study-related documents, adverse events, and safety data from clinical studies - Undertake signal detection, evaluation, and management activities - Perform data analysis for safety signals and document work in the safety information management system - Author Safety Assessment Reports and collaborate with the GSO on safety documents and regulatory responses - Support risk management activities and prepare responses to regulatory inquiries - Contribute to new drug applications and other regulatory filings - Undertake activities delegated by the QPPV as outlined in the PV System Master File - Maintain a state of inspection readiness and serve as a representative for Health Authority Inspections and Internal Process Audits Qualifications Required: - Doctorate/Masters degree/Bachelors degree with 12 to 17 years of directly related experience - Preferably in Life Sciences with managerial experience and clinical/medical research expertise in a biotech/pharmaceutical/CRO setting - Knowledge and skills in pharmacovigilance regulations, drug development, safety data capture, safety database structure, MedDRA, safety data analysis, risk management, and product knowledge - Intermediate skills in various pharmacovigilance processes, document writing, risk management plans, statistical methods, biomedical literature review, organization, collaboration, critical assessment, scientific writing, and communication In summary, as a Global PV Sr. Scientist at Amgen, your role involves collaborating with various teams on safety assessment activities, directing the preparation and review of aggregate reports, supporting clinical trial safety, and contributing to regulatory filings. Your qualifications should include a strong background in pharmacovigilance, managerial experience, and expertise in life sciences with a focus on drug development and safety data analysis.,