Lead PVRM Safety Scientist, Pharmacovigilance (Remote)

Sumitomo Pharma; Montpelier (VT); Remote; USD 157,000 - 196,000; Full time

Benefits offered by this job

Remote work option

Job summary

Sumitomo Pharma America (SMPA) is seeking a Senior Manager, Pharmacovigilance Scientist to serve as primary PVRM contact for assigned programs. You will lead safety evaluation, risk management activities, and ensure governance processes are applied across compounds and products.

Responsibilities include leading SMT meetings, reviewing adverse events, coordinating with cross-functional teams, and supporting regulatory submissions.

Qualifications

• Minimum of a 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; 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 products.
• Coordinate responses to ad hoc safety issues and regulatory requests in collaboration with cross-functional colleagues.
• Review adverse event reports and relevant clinical coding to support safety assessments.
• Develop and maintain safety and risk-management documents and SOPs.

Skills

Pharmacovigilance

Signal detection

Safety data analysis

Regulatory submissions

Cross-functional teams

Leadership

Education

Bachelor's degree

Advanced degree preferred

Job description

Sumitomo Pharma America (SMPA) is seeking a Senior Manager, Pharmacovigilance Scientist to serve as primary PVRM contact for assigned programs. You will lead safety evaluation, risk management activities, and ensure governance processes are applied across compounds and products.

Responsibilities include leading SMT meetings, reviewing adverse events, coordinating with cross-functional teams, and supporting regulatory submissions.