Remote Pharmacovigilance: Patient Safety Associate I

Parexel; United States; Remote; USD 60,000 - 85,000; 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 operations, process case reports, literature reviews, regulatory submissions, and affiliate services across global teams.

Handoffs and documentation follow SOPs, with supervision to ensure compliance and timely delivery. This role offers flexibility to work from home in the United States and opportunities to grow in drug safety and regulatory affairs.

Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, Biomedical Sciences or equivalent education/experience.
• Foundational knowledge of drug safety regulations and pharmacovigilance processes.
• 2+ years experience in post marketing.
• Experience in multiple therapeutic areas (cardiology, neurology, oncology, rare disease).
• 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 and ability to learn safety systems/databases. Preference for those with Veeva Safety experience.

Responsibilities

• Monitor incoming safety reports from multiple sources and support timely processing of pharmacovigilance data.
• Perform data entry, case creation, case processing, quality checks, coding activities, follow up activities, and case narrative preparation within safety databases in accordance with client requirements and standard operating procedures.
• Support compliance with 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

Organization

Attention to detail

Analytical thinking

Collaboration

Patient-focused

Pharmacovigilance knowledge

Education

Bachelor's degree in Life Sciences/Health Sciences/Biomedical Sciences or equivalent education/experience

Tools

Veeva Safety

MS Office

Job description

Parexel is seeking a Patient Safety Associate I to join our pharmacovigilance team. You will support safety operations, process case reports, literature reviews, regulatory submissions, and affiliate services across global teams.

Handoffs and documentation follow SOPs, with supervision to ensure compliance and timely delivery. This role offers flexibility to work from home in the United States and opportunities to grow in drug safety and regulatory affairs.