Soterius, Inc.
Website:
soterius.com
Job details:
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 ICSRs, signal reports, aggregate reports, and other safety information.
3. Signal Management & Risk Management
- 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 escalate concerns related to quality, resourcing, or timelines to functional leadership.
7. People Leadership & Talent Development
- 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 ICSRs (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.
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