Remote Pharmacovigilance Associate I

Parexel International; Northern (KY); Hybrid; USD 55,000 - 75,000; 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 International is hiring a Patient Safety Associate I to join our pharmacovigilance team. The role focuses on safety data processing, literature review, and regulatory submissions to ensure compliant drug safety activities.

The position supports global safety operations and affiliate services, with opportunities to develop pharmacovigilance expertise while contributing to patient safety initiatives. Remote work from the US is available.

Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, Biomedical Sciences or equivalent education/experience.
• 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 ability to learn safety systems/databases. Preference for Veeva Safety experience.

Responsibilities

• Monitor incoming safety reports and support timely processing of pharmacovigilance data.
• Data entry, case creation, case processing, quality checks, coding, follow-up, and narrative preparation in safety databases.
• Support regulatory reporting requirements through accurate processing and tracking of safety cases.
• Conduct literature searches and monitor scientific literature for safety information.
• Manage submission of Individual Case Safety Reports and related documentation to authorities.

Skills

Organization

Attention to detail

Analytical thinking

Communication

Team collaboration

Problem solving

Education

Bachelor's degree in Life Sciences, Health Sciences, Biomedical Sciences

Tools

MS Office

Veeva Safety

Job description

Parexel International is hiring a Patient Safety Associate I to join our pharmacovigilance team. The role focuses on safety data processing, literature review, and regulatory submissions to ensure compliant drug safety activities.

The position supports global safety operations and affiliate services, with opportunities to develop pharmacovigilance expertise while contributing to patient safety initiatives. Remote work from the US is available.