Patient Safety Associate — Phoenix, AZ at Parexel

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 research.

You will be a crucial part of a global leader in Clinical Research Organization services, contributing to the mission of enhancing patient safety while developing your career in pharmacovigilance. The role offers the flexibility to work from home within the US, allowing you to balance professional growth with personal needs.

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 work 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, while managing Medical and Product Dictionary activities where applicable.

Your work is essential for maintaining compliance through quality reviews of safety deliverables, generating metrics for safety operations, and investigating late deliverable incidents. You will serve as a bridge between global operations and local safety affiliates, supporting communication, translations, and data reconciliation activities. This role is designed for someone who thrives in a collaborative team environment and is committed to the highest standards of quality and detail.

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

702, West Camelback Road, Alhambra, Phoenix, Maricopa County, Arizona, 85013, United States

Phoenix, Arizona

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 for safety reports
check_circleSubmit ICSRs and periodic safety reports to Health Authorities and stakeholders
check_circleManage Medical and Product Dictionary activities and ensure data accuracy
check_circleGenerate metrics and performance indicators for safety operations and quality reviews
check_circleSupport aggregate report development and study-specific safety document creation
check_circleMaintain regulatory systems, product registrations, and global safety reporting requirements

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

Preference for candidates with Veeva Safety experience.

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 for safety reports; 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

Patient Safety Associate I (Drug Safety Associate I) at Parexel is based in 702, West Camelback Road, Alhambra, Phoenix, Maricopa County, Arizona, 85013, 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.

Patient Safety Associate I (Drug Safety Associate I)

Make a Meaningful Impact in Global Patient Safety

About the Role

Equal Opportunity

Work location

Key Responsibilities

Requirements

Nice to Have

Similar Job Opportunities

Patient Safety Associate I (Drug Safety Associate I)

Patient Safety Associate I (Drug Safety Associate I)

Patient Safety Associate I (Drug Safety Associate I)

Skills, education and keywords

Frequently asked questions about Patient Safety Associate I (Drug Safety Associate I) at Parexel