Senior Pharmacovigilance Specialist

Senior Pharmacovigilance Specialist
Location-Remote-US (Hybrid in Fort Worth, TX if converted to permanent)

Compensation & Schedule
• Pay range: $45.00–$49.00 per hour
• Hours: Full-time, standard business hours
• Employment type: Temp-to-Hire

Role Impact
The Pharmacovigilance Specialist plays a critical role in ensuring patient safety and regulatory compliance through accurate management of adverse event data. This position supports drug and device safety surveillance by evaluating, processing, and reporting adverse events in accordance with FDA and Health Canada regulations. Success in this role ensures timely regulatory submissions, supports compliance initiatives, and contributes to continuous improvement of pharmacovigilance processes.

Key Responsibilities
• Evaluate incoming communications from multiple channels to identify potential adverse event reports and ensure accurate case intake and documentation
• Perform medical assessment of adverse event reports to determine seriousness, causality, and reporting requirements for regulatory agencies
• Compile, analyze, and submit expedited and periodic safety reports to regulatory authorities in compliance with global pharmacovigilance standards
• Coordinate follow-up activities with healthcare professionals, patients, and internal stakeholders to obtain complete case information
• Support internal audits, regulatory inspections, and signal detection activities, including preparation of quarterly safety trend reports

Minimum Qualifications
• Bachelor’s degree in a healthcare or scientific discipline required
• Five (5) or more years of experience in pharmacovigilance, drug safety, clinical research, or a pharmaceutical/biotechnology environment
• Working knowledge of FDA and Health Canada post-marketing safety regulations and pharmacovigilance processes

Core Tools & Systems
• ARGUS Safety Database or similar drug safety system
• Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Adverse event intake and case management systems
• Regulatory reporting platforms and safety databases
• Medical terminology and clinical documentation systems

Preferred Skills
• Healthcare certification such as RN, LVN, or Pharmacist strongly preferred
• Experience with medical devices, biologics, or combination products
• Strong communication skills with the ability to interact professionally with healthcare professionals, patients, and cross-functional teams

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