Senior Safety Specialist

Senior Safety Specialist

Company Name: PPD Development, L.P.

Salary: $75,800.00 - $126,300.00 per year

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. Work independently to receive, triage, manage, and reconcile adverse event reports, including those reported in scientific literature, in accordance with contractual and regulatory 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. 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). Collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third party vendors. Interact with clients, health care professionals, clinical trial personnel, and consumers. Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise. 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. Prepare for and attend Audits and/or Bid Defenses, including presentations at client/investigator meetings, and review of metrics and budget considerations. 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 regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures, and proposals. Lead: Provide guidance / mentoring to a small unit or group performing the same or similar tasks where the majority of the time is spent performing the same or directly related individual tasks. Responsible for assigning, reviewing or checking work. May be required to complete tasks of unit members when the need arises. Operate in a lead capacity. Provide assistance in the development of program and departmental procedural documents. Mentor less experienced staff. Good knowledge and conduct of leading and completing project implementation, study maintenance, closeout activities and all related with minimal management oversight. Works independently and escalates to management as needed. Demonstrates awareness of financial monitoring tools (e.g. Clarity); Con-Mod Process; Budget issues. Provide budgetary oversight and maintenance on studies. Identifies any budgetary concerns and escalates and provides resolution as appropriate. Duties may be performed remotely.

Qualifications: Bachelor's degree in Pharmaceutical Science, Health Informatics, Biology, Nursing, or related field and five (5) years of experience in the job offered or as a Safety Specialist, Research Associate, Medical Technologist, Pharmacist, or related role. Must have five (5) years of experience with: Individual Case Safety Reporting or Drug coding software (ICSR); Computerized information systems and standard application software (Windows, MS Office); Pharmacovigilance safety reporting responsibilities inclusive of SAE receipt and reporting to clients; Therapeutic areas and experience required for processing SAEs and AESIs; Conduct and participate in PV specific Kick off meetings and client meetings with active participation from appliable key PV roles to ensure alignment, adherence to the SOW, and clear understanding of responsibilities and tasks by all parties; Ensure all tasks are performed in alignment with contracted scope, Safety Management Plan requirements, and applicable regulatory timelines; and Demonstrate accountability in identifying, reporting, and mitigating quality risks with the completion of Quality Events that impact assigned studies. Must have one (1) year of experience with: Database user interface and query software inclusive of Electronic Data Capture review and reconciliation to ensure accuracy and regulatory compliance; and Responsible for project implementation, maintenance and close out activities.