Director/Senior Director - Clinical Safety and 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

Director/Senior Director - Clinical Safety and Pharmacovigilance

15-20 years

Remote

Full-Time

Role Summary:

Clinical Safety & Pharmacovigilance will provide strategic and operational leadership across pharmacovigilance and clinical safety activities for clinical trial and post-authorization products. This role is responsible for end-to-end oversight of safety surveillance, medical review, signal management, aggregate reporting, compliance, quality, and team leadership, ensuring adherence to global regulatory requirements, client agreements, and industry best practices.

Key Responsibilities:

1. Strategic & Operational Leadership

• Provide overall leadership and ownership of assigned pharmacovigilance and clinical safety projects.
• Ensure effective planning, execution, and delivery of PV activities in line with client agreements, timelines, and quality expectations.
• Act as a senior medical and scientific authority for safety-related decisions across products and therapeutic areas.
• Support organizational growth by identifying process improvements, efficiencies, and best practices within pharmacovigilance operations.

2. Medical Review & Safety Assessment

• Conduct and oversee medical review and assessment of Individual Case Safety Reports (ICSRs) from clinical trials and post-authorization sources.
• Determine case reportability, seriousness, expectedness, and causality/relatedness.
• Review case narratives, source documents, adverse event selection, and MedDRA coding to ensure medical accuracy and regulatory compliance.
• Perform medical and scientific evaluation of safety data including ICSSR, signal reports, aggregate reports, and other safety information.
• Lead and oversee signal detection, evaluation, and management activities for innovator and marketed products.
• Implement and review signal detection methodologies in accordance with regulatory guidance.
• Contribute to clinical safety strategy, risk management planning, and benefit–risk assessments.
• Support ongoing safety surveillance and proactive risk identification across the product lifecycle.

4. Aggregate Reporting & Regulatory Deliverables

• Oversee and provide medical review for aggregate safety reports, including DSURs, PSURs/PBRERs, and other regulatory submissions.
• Ensure timely preparation, high-quality medical content, and compliance with global regulatory requirements.
• Collaborate with cross-functional stakeholders to support regulatory submissions and responses.

5. Quality, Compliance & Documentation

• Ensure compliance with applicable global regulations, guidelines, internal SOPs, and client-specific processes.
• Maintain oversight of quality, compliance, and documentation across all assigned PV projects.
• Author, review, and approve SOPs, work instructions, and other functional documents as assigned.
• Represent the function during internal audits, client audits, and regulatory inspections.

6. Project & Stakeholder Management

• Oversee project management activities, including workload planning, prioritization, and issue resolution.
• Communicate effectively with internal and external stakeholders, including clients, vendors, and cross-functional teams.
• Monitor project risks and elevate concerns related to quality, resourcing, or timelines to functional leadership.
• Provide line management and leadership to assigned team members.
• Guide, mentor, and develop team members to ensure high performance and professional growth.
• Identify training needs and support ongoing learning and capability building within the function.
• Monitor team workload and capacity, proactively addressing resourcing or performance challenges.

8. Additional Responsibilities

• Perform other pharmacovigilance and clinical safety activities as assigned to meet evolving organizational and client needs.

Qualifications & Experience

• Medical Degree (MBBS/MD required).
• 15+ years of progressive experience in pharmacovigilance and clinical safety, including:
• Medical review of ICSSR (SAEs in clinical trials and post-marketing)
• Signal detection and signal management
• Preparation and medical review of DSURs, PSURs/PBRERs
• Experience working with innovator molecules and across multiple therapeutic areas.
• Strong knowledge of global pharmacovigilance regulations and guidelines.
• Demonstrated leadership experience with strong decision-making and stakeholder management skills.
• Excellent written and verbal communication skills.