Senior PVRM Safety Scientist – Remote Lead

Sumitomo Pharma; Carson City (NV); A distancia; USD 157.000 - 196.000; Jornada completa

Descripción de la vacante

Sumitomo Pharma America (SMPA) seeks a Senior Pharmacovigilance Scientist to lead safety governance for assigned programs and collaborate across global development teams. You will drive risk management, signal evaluation, and regulatory responses while mentori ng cross-functional staff.

The role emphasizes proactive safety oversight, supporting submissions to FDA/EMA, and maintaining compliant PV processes in a primarily remote setting with periodic on-site meetings.

Formación

• Minimum 6 years of pharmacovigilance, drug safety, or related pharma/biotech experience.
• Experience with clinical safety activities, signal management, and aggregate reporting.
• Leadership of cross-functional activities is strongly preferred.

Responsabilidades

• Lead Safety Management Team (SMT) meetings and provide safety guidance for key documents.
• Contribute to signal detection, monitoring, and safety data interpretation across programs.
• Review adverse event reports and support safety assessments and regulatory responses.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, and Data Management.
• Prepare safety documents, including IBs, protocols, and CSR chapters, with vendor support as needed.
• Mentor SMT members and drive risk-management activities and submissions.
• Develop SOPs and supporting PVRM documents; contribute to inspection readiness.

Conocimientos

Pharmacovigilance

Signal detection

Safety data analysis

Regulatory submissions

Cross-functional collaboration

Project management

Educación

Bachelor's degree in healthcare, life science, or related field

Advanced degree preferred

Descripción del empleo

Sumitomo Pharma America (SMPA) seeks a Senior Pharmacovigilance Scientist to lead safety governance for assigned programs and collaborate across global development teams. You will drive risk management, signal evaluation, and regulatory responses while mentori ng cross-functional staff.

The role emphasizes proactive safety oversight, supporting submissions to FDA/EMA, and maintaining compliant PV processes in a primarily remote setting with periodic on-site meetings.