Senior Pharmacovigilance Scientist - PVRM Lead (Remote)

Sumitomo Pharma; Frankfort (KY); Remote; USD 157,000 - 196,000; Full time

Job summary

Sumitomo Pharma America, Inc. is seeking a Senior Manager, Pharmacovigilance Scientist to lead PVRM activities for assigned programs and collaborate with global teams.

You will guide safety evaluation, risk management, and governance processes to ensure robust pharmacovigilance across investigational and marketed products. You will chair SMT meetings, review adverse events, and support regulatory submissions while coordinating with Clinical Development, Regulatory Affairs, Biostatistics, and

Qualifications

• Bachelor’s degree in a healthcare, life science, or related scientific field; advanced degree preferred.
• Minimum 6 years of relevant pharmacovigilance, drug safety, or related pharmaceutical/biotechnology industry experience.
• Prior experience leading cross-functional activities, programs, or projects strongly preferred.
• Prior experience in oncology and/or neurology preferred.

Responsibilities

• Lead cross-functional Safety Management Team (SMT) meetings and provide safety guidance and input to key documents.
• Contribute to signal detection, monitoring, evaluation, interpretation, escalation, and communication of safety information.
• Maintain ongoing monitoring and assessment of safety profiles for assigned investigational and marketed products.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other functions; represent PVRM on cross-functional teams.
• Review adverse event reports, including serious cases, to support interpretation and quality across safety assessments.
• Review relevant clinical coding and support preparation/review of safety documents.
• Facilitate early identification and escalation of safety issues; serve as SMT Chair or Quorum member as assigned.
• Serve as a PVRM subject matter expert in review of protocols, interim reports, safety summary documents, and regulatory responses.
• Support preparation of individual case safety issues; conduct aggregate safety data analyses; contribute to submissions.
• Contribute to development/maintenance of safety and risk-management documents (RMPs, REMS).
• Work with PVRM and cross-functional teams to manage benefit-risk; ensure patient safety.
• Review literature search strategies and monitoring activities; incorporate findings into safety evaluations.
• Participate in aggregate safety report activities with vendor support.
• Coordinate responses to regulatory queries in collaboration with medical colleagues.
• Develop SOPs and work instructions for PVRM processes.
• Contribute to inspection readiness and continuous improvement initiatives.
• Support safety input for cross-functional projects and promote regulatory compliance.

Skills

Pharmacovigilance

Signal detection

Aggregate safety reports

Cross-functional collaboration

Regulatory submissions

Leadership

Communication skills

Education

Bachelor’s degree in healthcare or life sciences

6+ years pharmacovigilance/drug safety experience

Oncology/Neurology experience preferred

Job description

Sumitomo Pharma America, Inc. is seeking a Senior Manager, Pharmacovigilance Scientist to lead PVRM activities for assigned programs and collaborate with global teams.

You will guide safety evaluation, risk management, and governance processes to ensure robust pharmacovigilance across investigational and marketed products. You will chair SMT meetings, review adverse events, and support regulatory submissions while coordinating with Clinical Development, Regulatory Affairs, Biostatistics, and