Remote Senior PVRM Safety Scientist Lead

Sumitomo Pharma; Columbus (OH); Remote; USD 157,000 - 196,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Job summary

Sumitomo Pharma America (SMPA) is seeking a Senior Manager, Pharmacovigilance Scientist to act as the primary PVRM contact for assigned programs and to lead safety evaluation and risk management activities across cross-functional teams.

You will review adverse events, contribute to signal detection, and support regulatory submissions while collaborating with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and partners in a primarily remote role with travel as needed.

Qualifications

• Bachelor's degree in healthcare, life sciences, or related field (advanced degree preferred).
• Minimum 6 years' pharmacovigilance, drug safety, or related pharma/biotech experience.
• Experience in oncology and/or neurology is preferred.

Responsibilities

• Lead Safety Management Team (SMT) meetings and guide safety documents (IBs, ICFs, protocols, study reports).
• Contribute to signal detection, monitoring, evaluation, and escalation of safety information.
• Monitor safety profiles for investigational and marketed products and support benefit-risk assessments.
• Collaborate with Clinical Development, Regulatory, Biostatistics, Data Management, and other functions.
• Review adverse event reports, including serious cases, for quality and consistency.
• Review clinical coding and support safety documents (IBs, protocols, CSRs, etc.).
• Facilitate early safety issue escalation; serve as SMT Chair or quorum member.
• Act as PVRM SME in protocol reviews, interim reports, and regulatory responses.
• Support preparation of safety summaries, ISS/SCS, and risk-mitigation strategies.
• Develop and maintain PVRM SOPs and risk-management documents (RMPs, REMS).
• Contribute to inspection readiness and cross-functional safety initiatives.
• Support safety input for projects and promote a Patient First culture.

Skills

Pharmacovigilance

Drug safety

Signal detection

Safety data analysis

Regulatory submissions

Cross-functional collaboration

GVP/ICH knowledge

Education

Bachelor's degree in healthcare / life sciences

Job description

Sumitomo Pharma America (SMPA) is seeking a Senior Manager, Pharmacovigilance Scientist to act as the primary PVRM contact for assigned programs and to lead safety evaluation and risk management activities across cross-functional teams.

You will review adverse events, contribute to signal detection, and support regulatory submissions while collaborating with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and partners in a primarily remote role with travel as needed.