Patient Safety Associate — Tallahassee, FL 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 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 to monitor safety operations. By maintaining regulatory systems and supporting global reporting configurations, you will help bridge the gap between global operations and local safety affiliates, ensuring seamless communication and compliance across international borders.

Hiring Process

Qualified candidates will be considered for employment without regard to legally protected status. We invite you to apply and join a team committed to excellence in patient safety.

Equal Opportunity

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

1463, West Indianhead Drive, Tallahassee, Leon County, Florida, 32301, United States

Tallahassee, Florida

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

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 those 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

In this Patient Safety Associate I (Drug Safety Associate I) at Parexel role, you 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

To qualify for the Patient Safety Associate I (Drug Safety Associate I) at Parexel position, applicants should have: 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 1463, West Indianhead Drive, Tallahassee, Leon County, Florida, 32301, 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

Hiring Process

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