Remote Senior PVRM Safety Scientist Lead

Sumitomo Pharma; Cheyenne (WY); À distance; USD 157 000 - 196 000; Plein temps

Avantages offerts par ce poste

Remote work options

Competitive benefits

Career advancement

Résumé du poste

Sumitomo Pharma America (SMPA) is seeking a Senior Manager, Pharmacovigilance Scientist to act as a primary PVRM contact for assigned programs and collaborate with cross-functional teams globally. This role leads safety evaluation and risk management activities within the safety governance framework.

Responsibilities include leading Safety Management Team meetings, signal detection, adverse event review, and preparation of safety documents while ensuring compliance with regulatory requirements

Qualifications

• Bachelor’s degree in healthcare, life science, or related field required.
• Minimum 6 years of pharmacovigilance/drug safety experience.
• Experience with FDA/EU pharmacovigilance requirements and GCP/GVP/ICH guidelines.

Responsabilités

• Lead SMT meetings and provide safety input to key documents (IBs, ICFs, protocols, study reports).
• Conduct signal detection, monitoring, evaluation, and safety data analysis.
• Review adverse event reports and aggregate safety data; support safety summaries and regulatory responses.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and cross-functional teams.
• Support development of risk-mitigation strategies and safety governance processes.
• Prepare and review safety-related documents and responses to authorities.

Connaissances

Pharmacovigilance

Safety governance

Signal detection

Cross-functional leadership

Regulatory submissions

Communication

Formation

Bachelor’s degree in healthcare or life sciences

Description du poste

Sumitomo Pharma America (SMPA) is seeking a Senior Manager, Pharmacovigilance Scientist to act as a primary PVRM contact for assigned programs and collaborate with cross-functional teams globally. This role leads safety evaluation and risk management activities within the safety governance framework.

Responsibilities include leading Safety Management Team meetings, signal detection, adverse event review, and preparation of safety documents while ensuring compliance with regulatory requirements