Remote Pharmacovigilance Associate I

Parexel; Columbia (SC); On-site; 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 is seeking a Patient Safety Associate I to join our global pharmacovigilance team, supporting safety data processing, regulatory compliance, and literature monitoring for patients worldwide. The role offers remote work from the US and collaboration across international teams.

You will gain exposure to safety operations, case processing, and regulatory submissions while advancing your knowledge of drug safety and clinical research in a collaborative environment.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• Foundational knowledge of drug safety regulations and pharmacovigilance; 3 years in Drug Safety preferred.
• 2 years post-marketing experience.
• Experience across cardiology, neurology, oncology or rare diseases.
• Strong attention to detail, organizational skills, and problem solving ability.
• Effective communication and willingness to work in a collaborative team environment.
• Proficiency with MS Office; ability to learn safety systems; Veeva Safety experience preferred.

Responsibilities

• Monitor incoming safety reports from multiple sources and support timely processing.
• Perform data entry, case creation, case processing, quality checks, coding activities, follow up activities, and case narrative preparation within safety databases.
• Support regulatory reporting requirements through accurate processing, documentation, reconciliation, and tracking of safety cases and submissions.
• Conduct literature searches, screen and review scientific literature, identify potential safety information, and support literature monitoring activities.
• Manage submission of Individual Case Safety Reports, periodic reports, and related documentation to regulatory authorities and other stakeholders.
• Support affiliate services activities, including safety information exchange, literature screening coordination, translation support, follow up activities, and data reconciliation.
• Maintain documentation, records, and project files in applicable systems, including EDMS and eTMF environments.
• Support regulatory operations by maintaining regulatory databases, tracking submissions, supporting registrations, and assisting with lifecycle management activities.
• Participate in regulatory intelligence activities by researching, maintaining, and updating country specific safety reporting requirements and associated records.
• Participate in project meetings, training programs, audits, inspections, and other assigned departmental activities while escalating issues to supervisors as appropriate.

Skills

Organizational skills

Pharmacovigilance interest

Team collaboration

Quality and compliance

Pharmacovigilance systems

Continuous learning

Education

Bachelor’s degree in Life Sciences or related field

Tools

Veeva Safety

MS Office

Job description

Parexel is seeking a Patient Safety Associate I to join our global pharmacovigilance team, supporting safety data processing, regulatory compliance, and literature monitoring for patients worldwide. The role offers remote work from the US and collaboration across international teams.

You will gain exposure to safety operations, case processing, and regulatory submissions while advancing your knowledge of drug safety and clinical research in a collaborative environment.