Remote Patient Safety Associate I

Parexel; Montpelier (VT); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

FSA & HSA

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 US-based team. You will contribute to safety operations, case processing, literature monitoring, and regulatory support to help ensure safe and compliant drug development for patients worldwide.

In this role you will work under supervision within established procedures and with global colleagues, gaining exposure to pharmacovigilance processes, safety databases, and regulatory submissions while supporting

Qualifications

• Bachelor’s degree in Life Sciences or equivalent education/experience.
• 3+ years experience in Drug Safety; 2+ years post-marketing.
• Experience across multiple therapeutic areas (cardiology, neurology, oncology, rare disease).
• Strong attention to detail, organization, and problem solving.
• Effective communication and teamwork; proficient with MS Office and safety systems.

Responsibilities

• Monitor incoming safety reports and support timely processing.
• Data entry, case creation, processing, quality checks, coding, follow-ups, and case narratives.
• Support regulatory reporting through documentation, reconciliation, and tracking.
• Conduct literature searches and safety monitoring activities.
• Manage submissions to regulatory authorities and stakeholders.
• Coordinate affiliate services, translations, and data reconciliation.
• Maintain documentation in EDMS/eTMF and safety systems.
• Assist with regulatory intelligence and lifecycle management activities.
• Participate in meetings, audits, trainings, inspections, and escalate issues.

Skills

Organization skills

Attention to detail

Analytical thinking

Communication

Team collaboration

Pharmacovigilance systems

MS Office

Learning mindset

Education

Bachelor’s degree in Life Sciences

Equivalent education/experience

Tools

Veeva Safety

Safety databases

Job description

Parexel is seeking a Patient Safety Associate I (Pharmacovigilance Associate) to join our US-based team. You will contribute to safety operations, case processing, literature monitoring, and regulatory support to help ensure safe and compliant drug development for patients worldwide.

In this role you will work under supervision within established procedures and with global colleagues, gaining exposure to pharmacovigilance processes, safety databases, and regulatory submissions while supporting