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  1. Home
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  5. Patient Safety Associate I (Drug Safety Associate I)
Parexel logo

Patient Safety Associate I (Drug Safety Associate I)

Not Disclosed•Full-TimeRemote

location_on1504, Hawkins Street, Nashville, Davidson County, Middle Tennessee, Tennessee, 37203, United States

Apply Now

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 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.

About the Role

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.

Hiring Process

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.

Equal Opportunity Employer

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 location

Work model: Remote

location_on

1504, Hawkins Street, Nashville, Davidson County, Middle Tennessee, Tennessee, 37203, United States

Nashville, Tennessee

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Patient Safety Associate I (Drug Safety Associate I)

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
A Patient Safety Associate I (Drug Safety Associate I) at Parexel is responsible for the following: 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.
Where is the Patient Safety Associate I (Drug Safety Associate I) role at Parexel located?expand_more
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Key Responsibilities

  • check_circleProcess Individual Case Safety Reports (ICSRs) from multiple sources with accuracy and efficiency
  • check_circleConduct comprehensive literature searches and reviews to identify safety signals
  • check_circlePrepare medically cohesive case narratives and perform MedDRA coding
  • check_circleSubmit ICSRs and periodic safety reports to Health Authorities and stakeholders
  • check_circleMaintain regulatory submission schedules and ensure adherence to reporting rules
  • check_circleManage Medical and Product Dictionary activities and data reconciliation
  • check_circleConduct quality reviews of safety deliverables and generate performance metrics
  • check_circleResearch and maintain global safety reporting requirements in regulatory intelligence databases
  • check_circleSupport communication between global operations and local safety affiliates
  • check_circleSupport aggregate report development and study-specific safety document creation
  • check_circleAssist with regulatory submissions including eCTD, renewals, and lifecycle management

Requirements

  • verifiedBachelor's degree in Life Sciences, Health Sciences, or Biomedical Sciences (or equivalent)
  • verified3+ years experience in Drug Safety
  • verified2+ years experience in post-marketing
  • verifiedExperience in multiple therapeutic areas (cardiology, neurology, oncology, rare disease)
  • verifiedProficiency with MS Office
  • verifiedVeeva Safety experience preferred

Nice to Have

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 logo
Company

Parexel

Industry

scientific & qa

View company profilearrow_forwardlanguageWebsite
Quick Overview

Experience

3+ yrs (Mid Level)

Education

Bachelor's degree in Life Sciences, Health Sciences, or Biomedical Sciences or equivalent education/experience

Job Type

Full-Time

Skills Required

Drug SafetyClinical TrialsPost-Marketing SurveillanceRegulatory RequirementsStandard Operating ProceduresSops

Parexel • Phoenix, Arizona

Not Disclosedarrow_forward
Patient Safety Associate I (Drug Safety Associate I) at Parexel is based in 1504, Hawkins Street, Nashville, Davidson County, Middle Tennessee, Tennessee, 37203, United States. This is a remote role.
Is this Patient Safety Associate I (Drug Safety Associate I) job remote, hybrid, or on-site?expand_more
Parexel has listed this Patient Safety Associate I (Drug Safety Associate I) role as remote.
How much experience is required for this Patient Safety Associate I (Drug Safety Associate I) role?expand_more
Patient Safety Associate I (Drug Safety Associate I) at Parexel typically requires 3+ years of relevant experience at the mid level level.
What skills do you need for the Patient Safety Associate I (Drug Safety Associate I) role at Parexel?expand_more
Key skills for Patient Safety Associate I (Drug Safety Associate I) at Parexel include Drug Safety; Clinical Trials; Post-Marketing Surveillance; Regulatory Requirements; Standard Operating Procedures; Sops; Individual Case Safety Reports; and Icsrs.
What education is required for Patient Safety Associate I (Drug Safety Associate I) at Parexel?expand_more
Educational requirements for this role: Bachelor's degree in Life Sciences, Health Sciences, or Biomedical Sciences or equivalent education/experience.
What category does the Patient Safety Associate I (Drug Safety Associate I) role belong to?expand_more
Patient Safety Associate I (Drug Safety Associate I) at Parexel is part of the scientific & qa job category on Recrutus.
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Individual Case Safety Reports
Icsrs
Literature Searches
Signal Detection