Senior PVRM Safety Scientist Lead (Remote)

Sumitomo Pharma; Juneau (AK); Remote; USD 157,000 - 196,000; Full time

Job summary

Sumitomo Pharma America (SMPA) is seeking a Senior Manager, Pharmacovigilance Scientist to serve as the primary PVRM contact for assigned programs and to lead safety evaluation and risk management activities.

You will collaborate with Clinical Development, Regulatory Affairs, Biostatistics and Data Management, oversee safety governance, review adverse events, and help prepare safety documents and regulatory responses.

Qualifications

• Minimum of a bachelor’s degree in a healthcare, life science, or related scientific field; advanced degree preferred.
• Minimum 6 years of relevant pharmacovigilance, drug safety, or related pharmaceutical/biotechnology industry experience.
• Prior experience leading cross-functional activities, programs, or projects strongly preferred.

Responsibilities

• Lead cross-functional Safety Management Team (SMT) meetings and provide safety guidance and input to key documents.
• Contribute to signal detection, monitoring, evaluation, interpretation, escalation, and communication of safety information.
• Maintain ongoing monitoring and assessment of safety profiles for assigned products.

Skills

Pharmacovigilance

Signal detection

Regulatory submissions

Cross-functional leadership

Project management

Communication skills

GCP/GVP/ICH

Education

Bachelor's degree

Advanced degree preferred

Job description

Sumitomo Pharma America (SMPA) is seeking a Senior Manager, Pharmacovigilance Scientist to serve as the primary PVRM contact for assigned programs and to lead safety evaluation and risk management activities.

You will collaborate with Clinical Development, Regulatory Affairs, Biostatistics and Data Management, oversee safety governance, review adverse events, and help prepare safety documents and regulatory responses.