Summary: The role of Safety Scientist in Global Patient Safety IV involves working for a major pharmaceutical company focused on enhancing patient care through global collaboration. The position emphasizes expertise in pharmacovigilance and drug safety, particularly in the context of clinical studies. The role is remote, allowing for flexibility while contributing to critical safety assessments.

Key Responsibilities:

• Conduct pharmacovigilance and drug safety assessments.
• Manage and analyze data from Phase 1-3 clinical studies.
• Develop protocols, Investigator's Brochures (IB), and Informed Consent Forms (ICF).
• Review and analyze Serious Adverse Events (SAE) and aggregate data.
• Perform signal detection and evaluation.
• Author Development Safety Update Reports (DSUR).

Key Skills:

• Pharmacovigilance
• Drug safety
• Phase 1-3 clinical study experience
• Protocol, IB, ICF development
• SMC, DMC
• SAE and aggregate data review and analysis
• Signal detection and signal evaluation
• DSUR authoring

Salary (Rate): 85

City: Sacramento

Country: United States

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: Other