Remote Senior Pharmacovigilance Lead – Safety & Risk

Sumitomo Pharma; Augusta (ME); À distance; USD 157 000 - 196 000; Plein temps

Résumé du poste

Sumitomo Pharma America (SMPA) is seeking a Senior Manager, Pharmacovigilance Scientist to lead safety governance for assigned programs. You will guide SMTs, review IBs, ICFs and study reports, and ensure robust benefit-risk assessment across global teams.

Joining SMPA means working remotely with periodic on-site meetings, traveling as needed. A strong background in pharmacovigilance, signal management, and regulatory submissions is required for this senior role.

Qualifications

• Bachelor’s degree in healthcare, life science or related field.
• Minimum 6 years of pharmacovigilance or drug safety experience.
• Experience with safety reports and regulatory submissions.
• Oncology and/or neurology experience preferred.
• FDA/EU pharmacovigilance knowledge.

Responsabilités

• Lead cross-functional Safety Management Team (SMT) meetings and provide safety guidance on key documents.
• Contribute to signal detection, monitoring and safety data interpretation.
• Maintain ongoing monitoring of safety profiles for investigational and marketed products.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics and Data Management.
• Review adverse event reports to support proper interpretation and QA.
• Support preparation of safety documents and regulatory responses.
• Serve as PVRM SME in protocols, SAS reports and regulatory interactions.
• Develop and maintain safety/RMP/REMS documents as applicable.
• Ensure compliance with safety governance and regulatory requirements.

Connaissances

Pharmacovigilance

Signal detection

Safety data analysis

Regulatory submissions

Cross-functional collaboration

Leadership

Formation

Bachelor’s degree in healthcare or life sciences

Advanced degree preferred

Description du poste

Sumitomo Pharma America (SMPA) is seeking a Senior Manager, Pharmacovigilance Scientist to lead safety governance for assigned programs. You will guide SMTs, review IBs, ICFs and study reports, and ensure robust benefit-risk assessment across global teams.

Joining SMPA means working remotely with periodic on-site meetings, traveling as needed. A strong background in pharmacovigilance, signal management, and regulatory submissions is required for this senior role.