Skilled Pharmacovigilance Specialist focused on maximizing successful client outcomes through effective use of adverse event reporting, training compliance management, and quality assurance measures. Top-notch communicator with excellent time management, administrative and customer service skills.
· Followed all company policies and procedures to deliver quality work.
· Developed strong client relationships through consistent communication and attentive service.
· Improved customer satisfaction rates through proactive problem-solving and efficient complaint resolution.
· Interpreted clients' needs and introduced services to fit specific requirements.
· Creation of cases in Argus Safety for adverse events relating to the COVID-19 vaccine manufactured by Novavax.
· Monitor inbox for incoming adverse event reports, and process reports in a timely manner.
Upholding quality standards for case reporting timelines.
· Performing data migration using MS Excel and Argus safety for Novavax.
· Assist in the implementation and maintenance of programs and processes in relation to document control.
· Ensuring that document control requirements are met throughout the duration of a document‘s Lifecyle.
· Perform QC of client cases to ensure accuracy and compliance
· Supporting the delivery of training on Document Management and Control processes and the use of the Document Management System.
· Following EU regulatory reporting guidelines and completion of cases within the specified time frame.
· Use of ATC coding to appropriately code concomitant and suspect medications.
· Follow regulatory Standard Operating Procedure guidelines.
· Advanced knowledge of regulatory affairs and regulatory compliance requirements.
· Perform ICSR check before submitting case to quality control.
· Capturing Adverse events through the electronic data capturing system.
· Writing ICSR narratives in accordance with the client's data entry manual.
· Metrics reporting to maintain 100% compliance in Quality Management System.
· Proficient use of Citrix Workspace
· Creating Excel spreadsheets to document cases in various workflow stages.
· Accurate MedDRA coding of adverse events
· Accurate coding of pharmaceutical drugs using WHODrug global and NIH daily med.
· Prepare written communications to obtain follow-up information.
· MedWatch/CIOMS/E2B Preparation: Write case narratives and review MedWatch/CIOMS/E2B reports.
· Receipt, processing, reporting, follow-up and reconciliation of adverse event reports from any source like clinical trials, literature, and post-marketing materials.