Lead PVRM Safety Scientist — Pharmacovigilance

Sumitomo Pharma America; United States; Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Sumitomo Pharma America seeks a Senior Manager, Pharmacovigilance Scientist to serve as the primary PV and risk management contact for assigned programs. You will lead safety governance across cross-functional teams and ensure timely, compliant safety evaluations.

You will oversee signal detection, AE review, and safety documentation, collaborating with Clinical Development, Regulatory Affairs, and Data Management. The role emphasizes risk mitigation and regulatory interaction.

Responsabilidades

• Lead cross-functional Safety Management Team (SMT) meetings and provide safety guidance to key documents (IBs, ICFs, protocols, study reports, regulatory responses).
• Contribute to signal detection, monitoring, evaluation, interpretation, escalation, and communication of safety information.
• Maintain ongoing monitoring of safety profiles for assigned products, supporting risk evaluation and benefit-risk assessment.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other functions; represent PVRM on cross-functional teams.
• Review adverse event reports to ensure quality across safety assessments; support aggregate safety data analysis.
• Support preparation and review of safety documents (IBs, CSRs, SSMS) and regulatory responses; contribute to risk-mitigation strategies.
• Develop and maintain PVRM SOPs and risk-management documents; coordinate with vendors for literature monitoring and aggregate safety reporting.

Descripción del empleo

Sumitomo Pharma America seeks a Senior Manager, Pharmacovigilance Scientist to serve as the primary PV and risk management contact for assigned programs. You will lead safety governance across cross-functional teams and ensure timely, compliant safety evaluations.

You will oversee signal detection, AE review, and safety documentation, collaborating with Clinical Development, Regulatory Affairs, and Data Management. The role emphasizes risk mitigation and regulatory interaction.