Orbis Clinical is seeking a remote-based Drug Safety Associate for 6 months.

Position Summary

The Drug Safety Associate is responsible for supporting pharmacovigilance operations through the intake, processing, evaluation, and reporting of adverse event cases in compliance with global regulatory requirements and company procedures. This role requires hands-on experience with safety databases, case processing activities, and safety administration functions within a sponsor environment.

Key Responsibilities

• Perform end-to-end processing of serious and non-serious adverse event cases within Argus Safety.
• Review, triage, and manage incoming safety reports from multiple sources, including healthcare professionals, patients, clinical studies, and business partners.
• Conduct case intake, data entry, medical coding, narrative writing, quality review, and case follow-up activities.
• Ensure accurate and timely case processing in accordance with company SOPs, FDA, EMA, ICH, and global regulatory requirements.
• Support submission readiness and compliance with reporting timelines for expedited and aggregate safety reporting.
• Monitor and manage pharmacovigilance shared mailboxes, ensuring timely routing and processing of safety-related communications.
• Assist with mailbox automation initiatives and workflow optimization projects to improve operational efficiency.
• Maintain safety documentation, tracking logs, and case metrics.
• Support reconciliation activities between safety, clinical, and medical information departments as required.
• Collaborate with internal stakeholders and external vendors to ensure efficient case management and data quality.
• Participate in quality control reviews and support audit/inspection readiness activities.
• Assist with administrative pharmacovigilance tasks, including document management, filing, and process improvement initiatives.

Qualifications

Required

• Bachelor's degree in Nursing (BSN) or equivalent healthcare/scientific discipline.
• Registered Nurse (RN) license preferred.
• 2–4 years of pharmacovigilance/drug safety experience within a pharmaceutical, biotechnology, or sponsor organization.
• Strong working knowledge of Argus Safety.
• Experience processing both serious and non-serious adverse event cases.
• Understanding of global pharmacovigilance regulations and GVP requirements.
• Experience managing safety mailboxes and case intake workflows.
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.

Preferred

• Experience supporting post-marketing and clinical trial safety activities.
• Knowledge of MedDRA and WHO Drug coding.
• Experience with safety case quality review and compliance monitoring.
• Familiarity with process automation, workflow improvements, and pharmacovigilance operational excellence initiatives.

Core Competencies

• Adverse Event Case Processing
• Argus Safety Database
• Serious & Non-Serious Case Management
• Pharmacovigilance Operations
• Safety Mailbox Management
• Regulatory Compliance
• Data Quality & Quality Review
• Process Improvement & Automation
• Cross-Functional Collaboration
• Attention to Detail

Compensation Details:

• Orbis Clinical provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location. 
• The Pay Range for this position is $40-$60 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k).

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.