Patient Safety Associate I (Drug Safety Associate I)

Parexel•Southport, NC

1d•Remote

About The Position

This role supports critical patient safety and pharmacovigilance activities that help ensure the safe and compliant development of therapies for patients worldwide. As a Patient Safety Associate I, you will contribute to a broad range of safety operations, including individual case safety report processing, safety submissions, literature review activities, affiliate support, regulatory support, and regulatory intelligence activities. Working within established procedures and under appropriate supervision, you will play an important role in maintaining compliance with global regulatory requirements and supporting the delivery of high quality patient safety services. You will gain exposure to a wide range of pharmacovigilance processes while collaborating with experienced professionals across global teams. This role offers an excellent opportunity to build expertise in drug safety, regulatory compliance, and clinical research while contributing to activities that help protect patients and support the development of innovative therapies.

Requirements

Bachelor’s degree in Life Sciences, Health Sciences, Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology) or equivalent education/experience.
Foundational knowledge of drug safety regulations and pharmacovigilance processes.
Ideal candidate has 3+ years experience in Drug Safety.
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.

Nice To Haves

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.