
location_on1504, Hawkins Street, Nashville, Davidson County, Middle Tennessee, Tennessee, 37203, United States
At Parexel, we are dedicated to improving patient health worldwide. As a Patient Safety Associate I, you will play a vital role in supporting drug safety, clinical trials, and post-marketing surveillance activities. This position ensures full compliance with regulatory requirements and Standard Operating Procedures (SOPs) while providing exposure to the broader landscape of clinical trials.
You will join a global leader in Clinical Research Organization services, contributing to the critical mission of maintaining patient safety while developing your career in pharmacovigilance. The role offers the flexibility to work from home within the US, allowing you to balance a meaningful career with your personal life.
In this position, you will be the backbone of our safety operations, processing Individual Case Safety Reports (ICSRs) from multiple sources with accuracy and efficiency. Your day-to-day involves conducting comprehensive literature searches to identify safety signals, tracking regulatory information updates, and assisting in the preparation of regulatory submissions. You will also contribute to the development of aggregate reports and study-specific safety documents, ensuring that every deliverable meets the highest standards of quality.
Collaboration is key to your success. You will work closely with team members to manage Medical and Product Dictionary activities, investigate late deliverable incidents, and generate metrics for safety operations. By maintaining adherence to international and local regulatory reporting requirements, you will directly influence the safety profile of life-saving medications.
Qualified candidates will be considered for employment without regard to legally protected status. For more information on our application process, please refer to the official career portal.
Parexel is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Work model: Remote
1504, Hawkins Street, Nashville, Davidson County, Middle Tennessee, Tennessee, 37203, United States
Nashville, Tennessee
Skills: Drug Safety, Clinical Trials, Post-Marketing Surveillance, Regulatory Requirements, Standard Operating Procedures, Sops, Individual Case Safety Reports, Icsrs, Literature Searches, Signal Detection.
Education: Bachelor's degree in Life Sciences, Health Sciences, or Biomedical Sciences or equivalent education/experience.
3+ years experience in Drug Safety, 2+ years experience in post marketing, experience in multiple therapeutic areas (cardiology, neurology, oncology, rare disease), and Veeva Safety experience.
Parexel • Phoenix, Arizona
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