Safety Reporting Specialist
Safety Reporting Specialist
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob 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 departments 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: Bachelors 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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Required Experience:
Unclear Seniority
Employment Type
Full-Time
