Remote Director, Clinical Safety & Pharmacovigilance

Soterius, Inc.; Oregon; Hybrid; USD 180,000 - 240,000; Full time

Job summary

Soterius, Inc. is seeking a Director/Senior Director of Clinical Safety and Pharmacovigilance for a fully remote, full-time role.

The candidate will provide strategic and operational leadership across PV activities with medical review, signal management, and regulatory deliverables for trials and post-authorization products. The role requires 15+ years in pharmacovigilance, a medical degree (MBBS/MD), and strong leadership with experience in DSUR/PSUR/PBRER processes and cross-functional

Qualifications

• Senior level pharmacovigilance leadership experience required.
• Must have medical degree MBBS/MD and 15+ years in PV/safety.
• Experience with DSURs/PSURs/PBRERs and signal management.

Responsibilities

• Provide strategic and operational leadership across PV and clinical safety projects.
• Act as medical/scientific authority for safety decisions across products.
• Lead safety surveillance, medical reviews, and aggregate reporting.
• Oversee DSURs/PSURs/PBRERs and regulatory submissions.
• Ensure global regulatory compliance, SOPs, and audits.
• Mentor and manage PV teams and cross-functional stakeholders.

Skills

Leadership

Regulatory knowledge

Medical review

Communication

Project management

Education

MBBS/MD

Job description

Soterius, Inc. is seeking a Director/Senior Director of Clinical Safety and Pharmacovigilance for a fully remote, full-time role.

The candidate will provide strategic and operational leadership across PV activities with medical review, signal management, and regulatory deliverables for trials and post-authorization products. The role requires 15+ years in pharmacovigilance, a medical degree (MBBS/MD), and strong leadership with experience in DSUR/PSUR/PBRER processes and cross-functional