Remote Patient Safety Associate I

Parexel; Dover (DE); Remote; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health Insurance

Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Patient Safety Associate I to support pharmacovigilance activities, case processing, literature review, and regulatory submissions. You will work with global teams, ensure compliance, and contribute to high-quality patient safety services.

The role offers US remote work with opportunities to grow in drug safety and regulatory operations. Ideal candidates bring 3+ years in pharmacovigilance, strong organization, and teamwork skills, plus proficiency in MS Office and PV

Qualifications

• Bachelor’s degree in Life Sciences or equivalent.
• 3+ years in Drug Safety/Pv and 2+ years post marketing.
• Experience across multiple therapeutic areas.
• Strong attention to detail, organization and problem solving.
• Clear communication and collaborative work style.
• MS Office proficiency; familiarity with safety systems.

Responsibilities

• Monitor incoming safety reports and support processing.
• Data entry, case creation, coding, QA checks in safety databases.
• Support regulatory reporting through accurate case tracking.
• Conduct literature searches and monitor safety literature.
• Submit ICs, periodic reports, and related docs to authorities.
• Support affiliate services and data reconciliation.
• Maintain EDMS/eTMF documentation and records.
• Assist regulatory operations and lifecycle activities.
• Contribute to regulatory intelligence on country rules.
• Attend meetings, audits, and training; escalate issues.

Skills

Organization

Attention to detail

Analytical thinking

Pharmacovigilance

Patient safety

Pharmaceutical development

Healthcare

Team collaboration

Communication

Patient focus

Quality compliance

PV systems

Databases

MS Office

Workflows

Learning mindset

Skill development

Clinical research

Education

Life Sciences degree

Tools

Veeva Safety

Job description

Parexel is seeking a Patient Safety Associate I to support pharmacovigilance activities, case processing, literature review, and regulatory submissions. You will work with global teams, ensure compliance, and contribute to high-quality patient safety services.

The role offers US remote work with opportunities to grow in drug safety and regulatory operations. Ideal candidates bring 3+ years in pharmacovigilance, strong organization, and teamwork skills, plus proficiency in MS Office and PV