Remote Senior PVRM Safety Scientist – Lead Drug Safety

Sumitomo Pharma; Jackson (MS); A distancia; USD 157.000 - 196.000; Jornada completa

Descripción de la vacante

Sumitomo Pharma America (SMPA) is seeking a Senior Manager, Pharmacovigilance Scientist to lead safety evaluation and risk management for assigned programs. This remote US, full-time role collaborates with global development teams and partners to ensure governance of safety activities.

You will chair Safety Management Team meetings, review adverse events, support regulatory submissions, and develop risk-mitigation strategies while building cross-functional relationships and ensuring compliance

Formación

• Bachelor’s degree in healthcare, life sciences, or related field.
• At least 6 years in pharmacovigilance or drug safety.
• Advanced degree preferred (PhD/MD).
• Experience preparing regulatory safety submissions (FDA/EMA).

Responsabilidades

• Lead Safety Management Team (SMT) meetings and provide safety guidance on key documents.
• Contribute to signal detection, monitoring, evaluation, interpretation, escalation, and communication of safety information.
• Maintain ongoing monitoring of safety profiles for investigational and marketed products.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Data Management and other functions.
• Review adverse event reports to support interpretation and quality of safety assessments.
• Review clinical coding and support preparation of safety documents and regulatory responses.
• Facilitate early identification and escalation of safety issues and serve as SMT Chair as assigned.
• Serve as PVRM expert in study protocols, interim reports, and regulatory responses.
• Support preparation of ISS and SCS and risk-mitigation strategy development.
• Develop and maintain safety and risk-management documents (RMPs, REMS).
• Work with cross-functional teams to manage benefit–risk and patient safety.

Conocimientos

Pharmacovigilance

Drug safety

Risk management

Safety data analysis

Cross-functional teamwork

Educación

Bachelor's degree in life sciences

Advanced degree preferred

Descripción del empleo

Sumitomo Pharma America (SMPA) is seeking a Senior Manager, Pharmacovigilance Scientist to lead safety evaluation and risk management for assigned programs. This remote US, full-time role collaborates with global development teams and partners to ensure governance of safety activities.

You will chair Safety Management Team meetings, review adverse events, support regulatory submissions, and develop risk-mitigation strategies while building cross-functional relationships and ensuring compliance