Patient Safety Associate I (Drug Safety Associate I)

Parexel•Southport, NC

1d•Remote

About The Position

Parexel is seeking a Patient Safety Associate I to support patient safety and pharmacovigilance activities that help ensure the safe and compliant development of therapies. The role covers individual case safety report processing, safety submissions, literature review, affiliate support, regulatory support, and regulatory intelligence. Working within established procedures and under appropriate supervision, the associate helps maintain compliance with global regulatory requirements and deliver high-quality patient safety services. The position provides exposure to pharmacovigilance processes and collaboration with experienced professionals across global teams. The role offers flexibility to work from home in the United States.

Requirements

Bachelor’s degree in Life Sciences, Health Sciences, or Biomedical Sciences (such as Pharmacy, Microbiology, Biochemistry, or Biotechnology), or equivalent education or experience.
Foundational knowledge of drug safety regulations and pharmacovigilance processes.
At least 2 years of experience in post-marketing.
Experience in multiple therapeutic areas, such as cardiology, neurology, oncology, or rare disease.
Strong attention to detail, organizational skills, and problem-solving ability.
Effective communication skills and willingness to work in a collaborative team environment.
Proficiency with Microsoft Office and ability to learn safety systems and databases.
Organization, analytical thinking, and clear communication skills; ability to collaborate effectively with team members.
Interest in pharmacovigilance, patient safety, pharmaceutical development, or healthcare environments.
Patient-focused mindset and commitment to quality and compliance.
Strong desire to learn, develop new skills, and contribute to clinical research and patient safety initiatives.

Nice To Haves

Three or more years of experience in Drug Safety is described as ideal.
Experience with Veeva Safety is preferred.

Responsibilities

Monitor incoming safety reports from multiple sources and support timely processing of pharmacovigilance data.
Perform data entry, case creation and processing, quality checks, coding, follow-up activities, and case narrative preparation in safety databases according to client requirements and standard operating procedures.
Support regulatory reporting compliance 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.
Manage submission of Individual Case Safety Reports, periodic reports, and related documentation to regulatory authorities and other stakeholders.
Support affiliate services, 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.
Research, maintain, and update country-specific safety reporting requirements and associated records as part of regulatory intelligence activities.
Participate in project meetings, training programs, audits, inspections, and other assigned departmental activities, and escalate issues to supervisors as appropriate.