Patient Safety Associate — Baton Rouge, LA 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 contributing to the development of aggregate reports and study-specific safety documents.

You will be part of a global leader in Clinical Research Organization services, where you can contribute to improving patient safety worldwide while developing your career in pharmacovigilance. The role offers the flexibility to work from home in the US.

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 include conducting comprehensive literature searches to identify safety signals, tracking regulatory information updates, and assisting in preparing and executing regulatory submissions. You will also manage Medical and Product Dictionary activities and perform quality reviews of safety deliverables.

This role is crucial for maintaining compliance through the generation of metrics and performance indicators for safety operations. You will investigate and document late deliverable incidents, ensuring adherence to international and local regulatory reporting requirements. Success in this role requires strong attention to detail, excellent organizational skills, and the ability to work collaboratively in a team environment.

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

328, West Ardenwood Drive, Ardenwood, Mid City, Baton Rouge, East Baton Rouge Parish, Louisiana, 70806, United States

Baton Rouge, Louisiana

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_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_circlePerform data entry in safety databases ensuring medical consistency and accuracy
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

Preference for those with Veeva Safety experience.

Skills, education and keywords

Skills: Pharmacovigilance, Drug Safety, Clinical Trials, Post-Market Surveillance, Meddra Coding, MS Office, Veeva Safety, Literature Search.

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 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

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 328, West Ardenwood Drive, Ardenwood, Mid City, Baton Rouge, East Baton Rouge Parish, Louisiana, 70806, 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 Pharmacovigilance; Drug Safety; Clinical Trials; Post-Market Surveillance; Meddra Coding; MS Office; Veeva Safety; and Literature Search.

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