Senior PVRM Safety Scientist (Remote) — Lead

Sumitomo Pharma; Phoenix (AZ); Remote; USD 157.000 - 196.000; Vollzeit

Zusammenfassung

Sumitomo Pharma America (SMPA) seeks a Senior Pharmacovigilance Scientist to lead safety evaluation and risk management for assigned programs, collaborating with global teams and partners to ensure risk governance and compliant safety assessments.

Responsibilities include review of adverse events, signal detection support, safety documentation preparation, and regulatory submission contributions within a fast-paced, global setting.

Qualifikationen

• Bachelor's degree in healthcare, life sciences, or related field.
• 6+ years of pharmacovigilance, drug safety, or related pharma/biotech experience.
• Oncology and/or neurology experience preferred.

Aufgaben

• Lead cross-functional Safety Management Team (SMT) meetings and provide safety guidance on key documents.
• Contribute to signal detection, monitoring, evaluation, and communication of safety information.
• Maintain ongoing monitoring of safety profiles for investigational and marketed products.
• Collaborate with Clinical Development, Regulatory Affairs and other functions; represent PVRM in cross-functional teams.
• Review adverse event reports to support interpretation and quality of safety assessments.

Kenntnisse

Pharmacovigilance expertise

Signal detection

Cross-functional leadership

Regulatory submissions

Ausbildung

Bachelor's degree in healthcare, life sciences, or related field

Jobbeschreibung

Sumitomo Pharma America (SMPA) seeks a Senior Pharmacovigilance Scientist to lead safety evaluation and risk management for assigned programs, collaborating with global teams and partners to ensure risk governance and compliant safety assessments.

Responsibilities include review of adverse events, signal detection support, safety documentation preparation, and regulatory submission contributions within a fast-paced, global setting.