Wayne McCullers

Experience

1. Safety Database Administrator

   Fhi Clinical Inc

   Sep 2023 — Present · Durham, NC, US

   Support the day-to-day running of applications to sustain Drug Safety objectives, including withoutlimitation Argus Safety, Nukleus Safetybase, MedDRA, WHO Drug Dictionary, and businessintelligence tools. Assist with the configuration of safety database for products, studies, user privileges and workflow.Perform programming, validation, and front-end advance conditions (e.g, query sets, generation of custom reports for data analysis, routine, and ad hoc data extractions) to meet internal business requirements based on contracted timelines. Ensure all safety database activities are completed in accordance with SOPs and other applicableregulations and understand how regulatory changes (EMA/FDA) may impact the department. Take part in impact analysis of changes to Drug Safety Systems identifying the risks and benefitsassociated with the change. Keep management aware of potential and actual issues and integrate. Risk management. Review documentation associated with pharmacovigilance SOPs as related to the safety database. Act as liaison with IT and vendors to support release and/or patches delivery. Train, assist and support the Pharmacovigilance Team and other end-users as a System and Database Administrator for technical support. Assist in developing solutions for ongoing improved pharmacovigilance. Evaluate proposed project ideas / software changes through technical impact analysis and estimated business value to contribute to decision-making. Manage safety system access requests (internal and external). Maintain up-to-date knowledge of regulatory requirements for safety reporting as it relates to the safety database. Manage safety database upgrades and change control processes. Provide guidance on additional projects as needed. Perform other tasks as may be required and agreed to from time to time.

Skills

• Healthcare
• Microsoft Excel
• Team Leadership
• Pharmaceutical Industry
• Sop
• Clinical Trials
• Administration
• Ich-Gcp
• Databases
• Clinical Research
• Access
• Data Entry
• Analysis
• CRO
• Clinical Development
• Software Documentation
• Ctms