Safety Reporting Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Company Name:                                                PPD Development, L.P.

Position Title:                                                     Safety Reporting Specialist

Location:                                                            929 North Front Street, Wilmington, NC 28401

Summary of Duties: Responsible for receipt, submission, and subsequent tracking of expedited and periodic safety reports pertaining to the department’s projects. Assists management in producing project metrics as required. Involved in projects and programs relating to safety reporting and may take a lead role on projects. Receives, prepares and submits safety reports to applicable parties. Escalates to lead and/or line manager if any issues are encountered. Ensures reports are submitted in compliance with regulatory timelines and country legislation. Assists in producing metrics and alerts manager to any quality or timeline issues. Participates on project teams and may lead projects of small to moderate scope. Provides training and support to other team members. Performs administrative tasks such as filing and the maintenance of safety reporting systems and information. Liaises with various departments around safety reporting tasks and the setting up of client accounts. Participates in audits where required and performs testing activities as needed. Shares ideas and suggestions with team members ensuring effective communication and participates in process improvement initiatives. Duties may be performed remotely.

Qualifications: Bachelor’s degree in Biological Science, Biology, Clinical Medicine, or related field and two (2) years of experience as a Safety Specialist/Associate, Clinical Research Coordinator/Associate, Pharmacist, or related role. In the alternative, the employer will accept three (3) years of experience as a Safety Specialist/Associate, Clinical Research Coordinator/Associate, Pharmacist, or related role. Must have Two (2) years of experience with: Medical terminology; Pharmacovigilance; Microsoft office and safety database functionality; Procedural documents and global safety reporting requirements, including FDA regulations and guidelines; Implementing Standard Operating Procedure directives to ensure process conformance; Receiving and tracking of drug safety information; Liasing with clients to ensure compliance with safety standards; and Prioritizing tasks to ensure timeline deliverables are met. Six (6) months of experience with: Individual Case Safety Reporting or Drug coding software (ICSR).

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