Senior Safety Scientist, Pharmacovigilance & Risk Management

Sumitomo Pharma; Hartford (CT); Remote; USD 128.000 - 160.000; Vollzeit

Zusammenfassung

Sumitomo Pharma America is seeking a Safety Scientist Manager to provide pharmacovigilance and risk management across product lifecycles. You will collaborate with PV, Medical Safety, and cross-functional partners to ensure patient safety and regulatory compliance.

The role includes leading signal detection, aggregate safety reporting, safety governance, and inspection readiness, while coordinating with external partners and PV physicians to drive data-driven risk mitigation.

Qualifikationen

• Bachelor’s level degree in a health care/life science related field.
• Master’s or other graduate degree preferred.
• Minimum 4 years experience within Pharmacovigilance and in the pharmaceutical industry.

Aufgaben

• Collaborate with PV and cross-functional teams to manage benefit–risk for assigned products.
• Lead signal detection activities, data assembly, and signal evaluation.
• Participate in aggregate safety reporting, data analysis, and writing sections with vendor support.
• Coordinate with PV Operations and cross-functional teams for safety governance.
• Respond to regulatory inquiries and maintain inspection readiness.
• Support external partnerships and safety oversight activities as applicable.

Kenntnisse

Pharmacovigilance

Signal detection

Safety reporting

Cross-functional

Regulatory knowledge

Ausbildung

Bachelor's in health care or life science

Master’s or graduate degree preferred

Jobbeschreibung

Sumitomo Pharma America is seeking a Safety Scientist Manager to provide pharmacovigilance and risk management across product lifecycles. You will collaborate with PV, Medical Safety, and cross-functional partners to ensure patient safety and regulatory compliance.

The role includes leading signal detection, aggregate safety reporting, safety governance, and inspection readiness, while coordinating with external partners and PV physicians to drive data-driven risk mitigation.