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Great project available via Techfirm as Pharmacovigilance Compliance and Reporting Specialist (m/w/d)Key Responsibilities:- Project management and authoring of aggregate safety reports (PSURs, DSURs, PADERs, local reports) in collaboration with the PV Scientist Lead13- Serve as a subject matter expert on safety requirements, company policies, and procedures related to pharmacovigilance activities2- Support process improvement initiatives and maintain compliance with global PV regulations- Manage the Aggregate Reports Master Schedule and worldwide legislation overview4- Coordinate and author responses to safety questions from regulatory authorities- Contribute to initiatives for process improvement in aggregate reporting, clinical trial safety oversight, and signal managementQualifications:...

MAIN DUTIES AND RESPONSIBILITIESSAFETY :- Assist in the administration, collection, investigation, analysis of data in occurrence reporting database,- Assist in the monitoring and management of the hazard identification and risk management database,- Assist in the development and continuous improvement of the SMS and ERP,- Assist in monitoring and advising on all SFS safety activities which may have an impact on safety,- Monitoring industry flight standards and safety concerns which may have an impact on SFS’s operations,- Develop and produce internal “Safety Is Our Business” information bulletins,- Develop and conduct Safety Surveys, SMS internal audits and inspections,- Prepare and process collection and analysis of data for Lessons Learned database,- Assist in development, monitoring an...