Senior Pharmacovigilance Leader - Remote

Sumitomo Pharma; Lansing (MI); Remote; USD 157.000 - 196.000; Vollzeit

Zusammenfassung

Sumitomo Pharma America (SMPA) is seeking a Senior Pharmacovigilance Scientist to lead safety governance for assigned programs and collaborate across global development teams. The role emphasizes safety evaluation, risk management, and cross-functional engagement with SMTs and regulatory bodies.

The position requires extensive experience in pharmacovigilance, signal management, and aggregate reporting, with strong communication skills and the ability to drive risk mitigation strategies in

Qualifikationen

• Bachelor’s degree in healthcare, life science, or related field.
• Minimum 6 years of pharmacovigilance, drug safety, or related experience.
• Experience leading cross-functional safety activities and programs in pharma/biotech.

Aufgaben

• Lead cross-functional Safety Management Team (SMT) meetings and provide safety guidance for core documents.
• Contribute to signal detection, evaluation, and safety data analysis.
• Monitor safety profiles for investigational and marketed products with benefit-risk assessment.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, and Data Management.
• Review adverse event reports (serious cases) for consistency and quality in safety assessments.
• Support preparation of safety documents, regulatory submissions, and responses.
• Coordinate safety issue escalations with regulatory authorities and cross-functional teams.

Kenntnisse

Pharmacovigilance

Signal detection

Safety data analysis

Regulatory submissions

Cross-functional leadership

Communication skills

Ausbildung

Bachelor’s degree in healthcare or life sciences

Jobbeschreibung

Sumitomo Pharma America (SMPA) is seeking a Senior Pharmacovigilance Scientist to lead safety governance for assigned programs and collaborate across global development teams. The role emphasizes safety evaluation, risk management, and cross-functional engagement with SMTs and regulatory bodies.

The position requires extensive experience in pharmacovigilance, signal management, and aggregate reporting, with strong communication skills and the ability to drive risk mitigation strategies in