Safety Specialist I - (US-OH-Cincinnati - 45999)

Minimum Education: None
Job Type: Full Time
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Responsibilities : Ensures completeness of AE worksheet and source documents. Interact closely with clinical and medical monitors, investigative site personnel and sponsor representatives until all follow-up information is obtained and queries are satisfactorily resolved. Enters and verifies each and every data field in Kendle safety database, or sponsor database as appropriate. Codes all adverse events, indications, medical history, and medications. Prepares narratives. Forwards reports in a timely fashion to safety medical officers. Participates in case quality assurance checks from above (medical officer or more senior safety specialist) and below (data entry staff). Collaborates with safety peers in order to maintain timelines and generation of reports to the sponsor and regulatory authorities. Provides periodic SAE and AE reports to Project Leaders, Medical Officers, sponsors, Regulatory Affairs, IRBs, and others as requested. Interact with Data Management and sites as required to resolve discrepancies between the clinical and safety database. Becomes familiar with regulatory regulations, in the Code of Federal Regulations and Guidelines of the International Committee of Harmonization. Communicates with sponsor safety representatives and other Kendle associates as necessary (i.e., CRAs, CDAs, PMs, etc.). Other duties and assignments as requested for the overall performance of the department and the company.

Requirements :Requires minimal travel. Assumes Safety Project Leader (SFPL) responsibilities as experience and skills permit: Develop and review project proposals. Review and provide Safety agreement to contracts. Single point of contact for information regarding the project. Primary safety contact with the sponsor. Prepare/approve project safety plan. Train personnel on the team. Reviews financial measures. Reviews associate and project performance metrics (including quality parameters, monthly budget reports, and changes in scope). Decision maker for the project. Coordinator of workload and work flow. Leader of group meetings. Technical resource (may be delegated). Approve invoices. Determines team membership with assistance from manager. First cut at project issue resolution. Periodic project status reviews with managers, Senior Director, and VP-Safety & Pharmacovigilance.

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