Remote Senior Safety Scientist – Pharmacovigilance

Sumitomo Pharma; Augusta (ME); Remote; USD 128,000 - 160,000; Full time

Job summary

Sumitomo Pharma Co., Ltd. is seeking a Safety Scientist Manager to provide pharmacovigilance and risk management support across product lifecycles.

This role collaborates with PV, Medical Safety, and cross-functional teams to manage benefit-risk, ensure patient safety, and support regulatory compliance. The position involves signal detection, aggregate safety reporting, safety governance, and inspection readiness, with opportunities to lead risk mitigation and respond to regulatory inquiries in

Qualifications

• Bachelor’s degree in health care or life sciences required.
• Master’s degree preferred.
• Minimum 4 years experience in pharmacovigilance in the pharmaceutical industry.
• Experience in oncology and/or neurology preferred.
• Strong knowledge of FDA/EU regulations (GVP/ICH) and safety reporting.

Responsibilities

• Collaborate with PV and cross-functional teams to manage benefit–risk for assigned products.
• Assist in signal detection activities and data assembly for evaluation.
• Lead aggregate safety reporting and contribute to safety sections with vendor support.
• Support safety governance activities and SMT meetings with program teams.
• Coordinate responses to regulatory inquiries and safety issues across functions.
• Contribute to inspection readiness and process improvement initiatives.

Skills

Pharmacovigilance

Safety surveillance

Regulatory knowledge

Cross-functional collaboration

Analytical thinking

Education

Bachelor’s degree in health care or life sciences

Master’s degree preferred

Job description

Sumitomo Pharma Co., Ltd. is seeking a Safety Scientist Manager to provide pharmacovigilance and risk management support across product lifecycles.

This role collaborates with PV, Medical Safety, and cross-functional teams to manage benefit-risk, ensure patient safety, and support regulatory compliance. The position involves signal detection, aggregate safety reporting, safety governance, and inspection readiness, with opportunities to lead risk mitigation and respond to regulatory inquiries in