Patient Safety Associate — Bismarck, ND 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 while developing your career in pharmacovigilance. This 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 regulatory submissions. You will also manage Medical and Product Dictionary activities and perform quality reviews of safety deliverables to generate metrics and performance indicators.

You will work collaboratively with team members to support basic compliance activities, documentation, and audit preparation. The role involves communicating between global operations and local safety affiliates, assisting with safety information exchange, and maintaining regulatory systems for product registrations. Your work is crucial in investigating and documenting late deliverable incidents and ensuring adherence to international and local regulatory reporting requirements.

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

2264, East Bismarck Expressway, Bismarck, Burleigh County, North Dakota, 58504, United States

Bismarck, North Dakota

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

Preference for those with Veeva Safety experience.

Skills, education and keywords

Skills: Pharmacovigilance, Drug Safety, Meddra Coding, MS Office, Veeva Safety, Ectd.

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.

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 2264, East Bismarck Expressway, Bismarck, Burleigh County, North Dakota, 58504, 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; Meddra Coding; MS Office; Veeva Safety; and Ectd.

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