Senior Safety Specialist

Work Schedule

Other

Environmental Conditions

Office

Job Description

Company Name : PPD Development, L.P.

Position Title : Senior Safety Specialist

Location : 929 North Front Street, Wilmington, NC 28401

Summary of Duties : Perform day-to-day adverse event reporting and subsequent Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines.

Collect, monitor, assess, evaluate, research, and track safety information. Coordinate and perform adverse event data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities.

Collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third party vendors.

Work independently to receive, triage, manage, and reconcile adverse event reports, including those reported in scientific literature, in accordance with contractual and regulatory timelines.

Manage adverse events and endpoints, which may include review of complex medical records, preparation of adverse event narratives, and coding of event terms utilizing MedDRA.

Assign preliminary seriousness and labeledness / listedness of event(s). Work within multiple databases. Interact with clients, health care professionals, clinical trial personnel, and consumers.

Operate in a lead capacity. Provide assistance in the development of program and departmental procedural documents. Prepare for and attend audits.

Mentor less experienced staff. Review regulatory / pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures, and proposals.

Maintain medical understanding of applicable therapeutic area and disease states. Participate in on-call duties for specific projects to ensure 24-hr coverage for safety reporting.

Review cases entered for quality, consistency, and accuracy, including review of peer reports. Prepare and maintain regulatory safety reports.

Implement and coordinate routine projects (e.g., Clinical Trials, Endpoint Assessment Committee / Data Safety Monitoring Committee), including presentations at client / investigator meetings, and review of metrics and budget considerations.

Duties may be performed remotely.

Qualifications : Bachelor’s degree in Health Informatics, Microbiology, Biology, Nursing, Pharmaceutical Science, Chemistry, or related field and five (5) years of experience with as a Safety Specialist, Research Associate, Medical Technologist, Pharmacist, or related role.

In the alternative, the employer will accept a Master’s degree in Health Informatics, Microbiology, Biology, Nursing, Pharmaceutical Science, Chemistry, or related field, and three (3) years of experience as a Safety Specialist, Research Associate, Medical Technologist, Pharmacist, or related role.

Must have two (2) years of experience with : Individual Case Safety Reporting or Drug coding software (ICSR); Database user interface and query software;

and Pharmacovigilance. Must have one (1) year of experience with : Computerized information systems and standard application software (Windows, MS Office).

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