Remote Drug Safety Associate I

Parexel; United States; Remote; USD 68,000 - 100,000; Full time

Benefits offered by this job

Health, 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 (Pharmacovigilance Associate) to join our safety team. You will support safety data processing, literature monitoring, and regulatory submissions under supervision.

This role offers exposure to global safety processes, regulatory compliance, and opportunities to develop expertise in drug safety and clinical research while contributing to patient protection.

Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, Biomedical Sciences or equivalent education/experience.
• Foundational knowledge of drug safety regulations and pharmacovigilance processes.
• 3+ years experience in Drug Safety.
• 2+ years experience in post marketing.
• Experience in multiple therapeutic areas (cardiology, neurology, oncology, rare disease).

Responsibilities

• Monitor incoming safety reports and support timely processing of pharmacovigilance data.
• Perform data entry, case creation, case processing, quality checks, coding, follow up, and case narrative preparation.
• Support regulatory reporting through accurate processing, documentation, reconciliation, and tracking of safety cases.
• Conduct literature searches and reviews to identify potential safety information.
• Manage submission of Individual Case Safety Reports and related documentation to regulatory authorities.
• Support affiliate services activities including safety information exchange and translation support.

Skills

Attention to detail

Analytical thinking

Communication

Team collaboration

Pharmacovigilance systems

Microsoft Office

Education

Bachelor’s degree in Life Sciences

Tools

Veeva Safety

Safety databases

Job description

Parexel is seeking a Patient Safety Associate I (Pharmacovigilance Associate) to join our safety team. You will support safety data processing, literature monitoring, and regulatory submissions under supervision.

This role offers exposure to global safety processes, regulatory compliance, and opportunities to develop expertise in drug safety and clinical research while contributing to patient protection.