Senior Safety Specialist

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Execute daily adverse event reporting and pharmacovigilance tasks in a rigorously regulated setting.

• Receive, assess, manage, and reconcile reports of adverse events, including scientific-literature reports.

• Gather, monitor, evaluate, research, and track safety-related information.

• Oversee the entry of adverse event data, coding, assessment, case review, follow-up, tracking, and regulatory submissions.

• Examine cases and peer reports for quality assurance, consistency, and precision.

• Prepare and maintain regulatory safety documentation.

• Implement and coordinate routine projects, including clinical trials and Endpoint Assessment/Data Safety Monitoring Committees.

• Collaborate with project teams, clients, investigators, reporters, and third-party vendors.

• Communicate with clients, healthcare professionals, clinical trial staff, and consumers.

• Act as a primary departmental liaison on various projects.

• Manage adverse events and endpoints, which includes complex medical record reviews, writing adverse event narratives, MedDRA coding, and assessing seriousness/listedness.

• Operate across multiple databases.

• Prepare for and participate in audits, bid defenses, client meetings, and investigator meetings.

• Review metrics and budget considerations; provide oversight on budgetary matters and escalate any concerns.

• Participate in on-call responsibilities to ensure 24-hour safety reporting coverage.

• Stay updated by reviewing regulatory and pharmacovigilance publications.

• Lead and mentor a small team or group; assign, review, and verify work.

• Contribute to the development of program and departmental procedural documents.

• Complete project implementation, study maintenance, and closeout tasks with minimal supervision.

• Work autonomously and escalate issues to management when necessary.

⛳️ Requirements

• Bachelor’s degree in Pharmaceutical Science, Health Informatics, Biology, Nursing, or a related field.

• At least five (5) years of experience in the offered position or as a Safety Specialist, Research Associate, Medical Technologist, Pharmacist, or a similar role.

• Five (5) years of experience with Individual Case Safety Reporting or Drug coding software (ICSR).

• Five (5) years of experience using computerized information systems and standard software applications (Windows, MS Office).

• Five (5) years of experience in pharmacovigilance safety reporting duties, including receipt and reporting of SAEs to clients.

• Five (5) years of experience working with therapeutic areas and processing SAEs and AESIs.

• Five (5) years of experience in conducting and participating in PV-specific kick-off and client meetings.

• Five (5) years of experience ensuring that tasks comply with contracted scope, Safety Management Plan requirements, and regulatory deadlines.

• Five (5) years of experience in identifying, reporting, and mitigating quality risks through Quality Events.

• One (1) year of experience with database user interface and query software, including Electronic Data Capture review and reconciliation.

• One (1) year of experience in project implementation, maintenance, and closeout activities.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• Supportive work environment focused on team collaboration.