Remote Patient Safety & Pharmacovigilance Associate I

Parexel; Oregon; Hybrid; USD 65,000 - 90,000; 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 to join our pharmacovigilance team. You will support safety data processing, literature screening, and regulatory submissions across global programs, while ensuring compliance with global requirements.

This role offers remote work from the US and exposure to diverse safety operations. You will collaborate with experienced teams, gain exposure to EDMS/eTMF environments, and contribute to high-quality patient safety services in a globally leading

Qualifications

• Bachelor's degree in Life Sciences or related field or equivalent education/experience.
• Foundational knowledge of drug safety regulations and pharmacovigilance processes; 3+ years in Drug Safety preferred.
• Experience in post-marketing pharmacovigilance and multiple therapeutic areas.

Responsibilities

• Monitor incoming safety reports and support timely processing of pharmacovigilance data.
• Perform data entry, case creation, coding, follow-up, and case narratives in safety databases.
• Support regulatory reporting through documentation, reconciliation, and submissions.
• Conduct literature searches and literature screening coordination.
• Submit safety reports, periodic reports, and related docs to authorities.
• Assist with affiliate services, translation support, and data reconciliation.
• Maintain regulatory databases and lifecycle management activities.
• Engage in regulatory intelligence on country-specific safety reporting requirements.
• Participate in meetings, audits, and training; escalate issues as needed.

Skills

Pharmacovigilance

Attention to detail

Analytical thinking

Collaboration

Clear communication

Database systems

MS Office

Willingness to learn

Education

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

Tools

MS Office

Veeva Safety

Job description

Parexel is seeking a Patient Safety Associate I to join our pharmacovigilance team. You will support safety data processing, literature screening, and regulatory submissions across global programs, while ensuring compliance with global requirements.

This role offers remote work from the US and exposure to diverse safety operations. You will collaborate with experienced teams, gain exposure to EDMS/eTMF environments, and contribute to high-quality patient safety services in a globally leading