Remote Pharmacovigilance Associate I

Regulatory Toolkit; United States; Remote; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Vacation/Holidays/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 and safety operations for therapies worldwide. You will process safety reports, conduct literature reviews, and assist with regulatory submissions while ensuring compliance and high-quality service.

Join a global team and develop expertise in drug safety, regulatory compliance, and clinical research with opportunities for growth and flexible work options in the US.

Qualifications

• Bachelor’s degree in Life Sciences or equivalent.
• 3+ years experience in Drug Safety / pharmacovigilance.
• 2+ years post marketing experience.
• Experience across multiple therapeutic areas (cardiology, neurology, oncology, rare disease).
• Proficient with MS Office; ability to learn safety systems; Veeva preferred.

Responsibilities

• Monitor incoming safety reports and support timely processing.
• Data entry, case processing, quality checks, coding, and case narrative prep.
• Support regulatory reporting requirements and safety submissions.
• Conduct literature searches and monitor safety information.
• Manage submission of safety reports to authorities and stakeholders.
• Maintain documentation in EDMS/eTMF and safety databases.
• Assist with lifecycle management and regulatory intelligence activities.
• Participate in meetings, audits, and training; escalate issues as needed.

Skills

Pharmacovigilance

Drug safety

Team collaboration

Attention to detail

Analytical thinking

Learning mindset

Education

Bachelor’s degree in Life Sciences

Equivalent education/experience

Tools

Veeva Safety

MS Office

Safety databases

Job description

Parexel is seeking a Patient Safety Associate I to support pharmacovigilance and safety operations for therapies worldwide. You will process safety reports, conduct literature reviews, and assist with regulatory submissions while ensuring compliance and high-quality service.

Join a global team and develop expertise in drug safety, regulatory compliance, and clinical research with opportunities for growth and flexible work options in the US.