Remote Safety Scientist Manager – Pharmacovigilance

Sumitomo Pharma; Atlanta (GA); À distance; USD 128 000 - 160 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k)

Paid time off

Holidays

Résumé du poste

Sumitomo Pharma America, Inc. is seeking a Safety Scientist Manager to lead pharmacovigilance activities across the product lifecycle, collaborating with PV, Medical Safety and cross‑functional teams to maintain patient safety, ensure regulatory compliance and support inspection readiness.

Responsibilities include signal detection, aggregate safety reporting, safety governance, and external partnerships, with emphasis on communication, data interpretation, and risk mitigation strategies to

Qualifications

• Bachelor’s degree in health care or life science field.
• Master’s degree preferred for advanced roles.
• Strong knowledge of pharmacovigilance principles across product lifecycle.

Responsabilités

• Collaborate with PV and cross‑functional teams to manage benefit‑risk and patient safety.
• Lead signal detection activities, literature monitoring, and safety surveillance.
• Prepare, review, and ensure inspection‑ready safety reports and aggregate safety data.
• Coordinate safety issues with regulators, clinical sites, and healthcare professionals.
• Represent PV operations in cross‑functional teams and SMT meetings.
• Support inspection readiness and continuous process improvements in PVRM.

Connaissances

Pharmacovigilance

Signal detection

Safety reporting

Risk management

Cross-functional collaboration

FDA/EMA knowledge

Data analysis

Communication

Formation

Bachelor’s in life sciences

Master’s degree preferred

Description du poste

Sumitomo Pharma America, Inc. is seeking a Safety Scientist Manager to lead pharmacovigilance activities across the product lifecycle, collaborating with PV, Medical Safety and cross‑functional teams to maintain patient safety, ensure regulatory compliance and support inspection readiness.

Responsibilities include signal detection, aggregate safety reporting, safety governance, and external partnerships, with emphasis on communication, data interpretation, and risk mitigation strategies to