Patient Safety Associate I (Drug Safety Associate I)
Not Disclosed•Full-TimeRemote
location_on2925, H Street, Marshall School, East Sacramento, Sacramento, Sacramento County, California, 95816, United States
Make a Meaningful Impact in Global Patient Safety
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 clinical trial landscape.
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 is designed for those with a strong commitment to quality and a desire to work collaboratively in a team environment.
About the Role
In this position, you will process Individual Case Safety Reports (ICSRs) from multiple sources with accuracy and efficiency. Your day-to-day activities will involve conducting comprehensive literature searches to identify safety signals, supporting signal detection and management, and tracking regulatory information updates. You will assist in preparing and executing regulatory submissions, contribute to the development of aggregate reports, and manage Medical and Product Dictionary activities where applicable.
A key part of your responsibility is maintaining compliance through quality reviews of safety deliverables. You will generate metrics and performance indicators for safety operations, investigate and document late deliverable incidents, and ensure adherence to international and local regulatory reporting requirements. This role serves as a crucial bridge between global operations and local safety affiliates, facilitating safety information exchange and data reconciliation.
Work Environment
This role offers the flexibility to work from home within the US.
Equal Opportunity
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Work location
Work model: Remote
2925, H Street, Marshall School, East Sacramento, Sacramento, Sacramento County, California, 95816, United States
Sacramento, California
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Skills, education and keywords
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.
Frequently asked questions about Patient Safety Associate I (Drug Safety Associate I) at Parexel
What does a Patient Safety Associate I (Drug Safety Associate I) at Parexel do?expand_more
Day-to-day, the Patient Safety Associate I (Drug Safety Associate I) at Parexel will process individual case safety reports (icsrs) from multiple sources with accuracy and efficiency; conduct comprehensive literature searches and reviews to identify safety signals; prepare medically cohesive case narratives and perform meddra coding; and submit icsrs and periodic safety reports to health authorities and stakeholders.
What are the requirements for this Patient Safety Associate I (Drug Safety Associate I) role?expand_more
Parexel is looking for candidates who meet the following requirements: Bachelor's degree in Life Sciences, Health Sciences, or Biomedical Sciences (or equivalent); 3+ years experience in Drug Safety; 2+ years experience in post-marketing; Experience in multiple therapeutic areas (cardiology, neurology, oncology, rare disease); Proficiency with MS Office; and Veeva Safety experience preferred.