Remote Pharmacovigilance Safety Scientist Manager

Sumitomo Pharma; Jackson (MS); Remoto; USD 128.000 - 160.000; Tempo pieno

Descrizione del lavoro

Sumitomo Pharma America, Inc. is seeking a Safety Scientist Manager to provide pharmacovigilance and risk management support for assigned products across their lifecycle.

The role collaborates with PV, Medical Safety, and cross‑functional stakeholders to manage benefit‑risk, ensure patient safety, and support regulatory compliance. The position contributes to signal detection, aggregate safety reporting, safety governance forums, and inspection readiness, while serving as a subject matter expert

Competenze

• Bachelor’s level degree in a health care/life science related field required.
• Master’s degree preferred.
• Minimum 4 years of pharmacovigilance experience in the pharmaceutical industry.
• Experience in oncology and/or neurology strongly preferred.
• Solid understanding of FDA/EU/GXP/ICH safety guidelines and related regulations.

Mansioni

• Lead benefit‑risk management and safety surveillance for assigned products across their lifecycle.
• Participate in and lead aggregate safety reporting activities with data compilation, analysis, and writing responsibilities.
• Represent PV Operations on cross‑functional teams and support safety governance activities.
• Coordinate responses to regulatory inquiries in collaboration with PV physicians.
• Contribute to inspection readiness, audits, and continuous process improvements within PV operations.
• Serve as a subject matter expert in pharmacovigilance for assigned programs and collaborate with external partners.

Conoscenze

Pharmacovigilance

Signal detection

Safety reporting

Regulatory knowledge

Formazione

Bachelor's degree in health care/life sciences

Master’s degree preferred

Descrizione del lavoro

Sumitomo Pharma America, Inc. is seeking a Safety Scientist Manager to provide pharmacovigilance and risk management support for assigned products across their lifecycle.

The role collaborates with PV, Medical Safety, and cross‑functional stakeholders to manage benefit‑risk, ensure patient safety, and support regulatory compliance. The position contributes to signal detection, aggregate safety reporting, safety governance forums, and inspection readiness, while serving as a subject matter expert