Senior Pharmacovigilance Safety Manager (Remote)

Sumitomo Pharma; Cheyenne (WY); Remote; USD 128,000 - 160,000; Full time

Job summary

Sumitomo Pharma America (SMPA) is seeking a Safety Scientist Manager to oversee pharmacovigilance and risk management for assigned products. This role collaborates with PV, Medical Safety, and cross-functional teams to manage safety profiles, ensure patient safety, and maintain regulatory compliance across the lifecycle.

The position involves contributing to signal detection, aggregate safety reporting, safety governance forums, and inspection readiness.

Qualifications

• Bachelor’s degree in a health care or life sciences field; Master’s degree preferred.
• Strong knowledge of pharmacovigilance, safety reporting, and regulatory guidelines (FDA/EU/ICH).
• Experience in oncology or neurology safety signals is preferred.

Responsibilities

• Lead benefit-risk assessment and safety surveillance across product lifecycle.
• Assist signal detection activities, data assembly, validation and evaluation.
• Prepare and review aggregate safety reports and safety governance materials.
• Coordinate safety responses with cross-functional teams and regulatory authorities.
• Support inspection readiness activities and safety oversight with external partners.

Skills

Pharmacovigilance

Risk management

Signal detection

Aggregate reporting

Safety governance

Education

Bachelor’s in health care or life sciences

Master’s degree (preferred)

Job description

Sumitomo Pharma America (SMPA) is seeking a Safety Scientist Manager to oversee pharmacovigilance and risk management for assigned products. This role collaborates with PV, Medical Safety, and cross-functional teams to manage safety profiles, ensure patient safety, and maintain regulatory compliance across the lifecycle.

The position involves contributing to signal detection, aggregate safety reporting, safety governance forums, and inspection readiness.