Independently manage ICSR triage, case processing, and quality control for global safety reports.
Perform SAE reconciliation between safety and clinical databases, ensuring compliance with timelines.
Support team development through training, onboarding, and process improvement initiatives.
This company is a partner organization focused on global pharmacovigilance operations. It is a fast-growing, internationally focused company with a collaborative culture emphasizing teamwork, excellence, and continuous improvement.
Lead complex hospital and professional billing compliance audits and investigations to identify risks and ensure regulatory alignment.
Analyze billing, coding, and operational data to uncover systemic issues and provide actionable recommendations to leadership.
Serve as a billing compliance subject matter expert, advising cross-functional teams and developing training and policies.
The company is a healthcare organization focused on billing compliance and risk management, providing auditing and advisory services. It offers a remote-first collaborative environment with opportunities to influence policies and work with senior leaders.
Manage reprocessing and infection control activities for the endoscopic product portfolio, serving as the primary company resource and subject matter expert.
Work cross-functionally with customers, third-party companies, and internal stakeholders to ensure reprocessing recommendations satisfy US market needs and comply with industry guidelines.
Develop validation programs, technical manuals, and educational tools while representing the company on national committees and keeping leadership informed of trends.
FUJIFILM Healthcare Americas Corporation provides cutting-edge healthcare solutions spanning diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, as well as in-vitro diagnostics. The company is part of Fujifilm, which has over 70,000 employees globally and is guided by a Group Purpose of giving our world more smiles, offering a dynamic and flexible work environment.
Support study execution by managing meeting logistics, documenting decisions, and tracking action items.
Partner with Clinical Operations and site monitors to ensure protocol compliance and quality standards.
Responsible for filing site-level documents into Trial Master Files and assisting with regulatory submissions.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. As a small, mission-driven team, we foster a collaborative culture built on trust, ownership, curiosity, and results.
Lead client-facing safety projects and serve as the primary point of contact for pharmacovigilance services.
Manage project scope, timelines, and deliverables while coordinating activities across PV teams.
Provide pharmacovigilance expertise including ICSR processing, aggregate reporting, and quality review.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. It uses a shortlisting process to ensure fair and objective application review, and the final hiring decisions are made by the partner company.
Lead portions of regulatory assessments, external audits, and accreditation processes for Commercial, Medicare, Medicaid, and Marketplace departments.
Act as primary point of contact for internal and external partners on regulatory activity, quality efforts, SOP development, and client delegation agreements.
Maintain regulatory gap status reporting, track work streams, and lead change management related to regulatory requirements.
Prime Therapeutics is a pharmacy benefit manager (PBM) with a purpose beyond profits, reimagining pharmacy solutions to connect care for those they serve. The company is a large, purpose-driven organization focused on simplifying healthcare and fostering a collaborative culture.
Create and maintain SOPs and guidance documents in compliance with ICH-GCP and federal and local regulations.
Conduct internal study reviews to ensure compliance and prepare official reports with findings and corrective actions.
Collaborate with operations teams to remediate noncompliance and participate in quality investigations and audits.
Headlands Research is dedicated to enhancing clinical trial delivery within communities. Founded in 2018, the company operates 20+ clinical trial sites across the US and Canada and is rapidly expanding.
Support and contribute to global regulatory strategies to expedite development and mitigate risks.
Plan, prepare, and coordinate regulatory documents for submissions to global health authorities (INDs, BLAs, MAAs, etc.).
Collaborate with cross-functional teams and support interactions with FDA and other Health Authorities.
Immunovant, Inc. is a clinical-stage immunology company developing targeted therapies for autoimmune diseases. As a rapid-growth biotech startup, it fosters a dynamic, fast-paced, and entrepreneurial environment.
Lead regulatory and quality strategy for product development and lifecycle management.
Coordinate regulatory submissions and maintain documentation for SaMD products.
Support design change assessments and ensure compliance with FDA, EU MDR, and ISO 13485.
Oura empowers people to own their inner potential through its award-winning Oura Ring and connected app, providing daily insights on readiness, activity, and sleep. As a quickly growing health technology company, Oura fosters a culture of empowerment and well-being, ensuring team members have the resources to do their best work.
Manage the intake, review, analysis, and reporting of Individual Case Safety Reports (ICSRs) and support Clinical Events Committees and Data Monitoring Committees.
Co-author and maintain study-specific safety documents and prepare aggregate safety reports for regulatory submission.
Collaborate with sponsors, study teams, and cross-functional partners to ensure data quality and compliance with GCP and GVP standards.
This partner company delivers high-quality safety services across clinical research and medical device programs. They foster a collaborative, detail-oriented environment with a focus on compliance and patient outcomes.