Clinical Safety Specialist

Planet Pharma are currently partnered with an exciting global medical device company and we are actively seeking a Clinical Safety Specialist to join the business fully remotely in Bulgaria. Key Responsibilities: Generate, review and prepare Clinical Study Safety reports in accordance with Clinical Safety Management and Potential Complaint Plans. Support the collection, compilation and delivery of information required for potential complaint investigations and regulatory reporting activities. Assist with data reconciliation processes and produce study listings to support data cleaning activities in line with key study milestones. Provide operational and technical support, including user training, documentation management, data extraction and activity tracking. Compile and analyse metrics from multiple data sources to support reporting and performance monitoring. Maintain Clinical Safety study documentation in compliance with Good Documentation Practice (GDP), ensuring appropriate workflow management and document distribution. Ensure Clinical Safety records are accurately maintained and filed within the Trial Master File. Support internal and external audit activities by ensuring study documentation is complete, accurate and inspection-ready. Coordinate Clinical Event Committee (CEC) preparation activities and provide post-meeting support where applicable. Utilise knowledge of company processes and systems to contribute to the development, implementation and continuous improvement of programmes, procedures and operational guidelines. Key Requirements: Degree in Scientific Discipline 1+ years experience About Planet Pharma: Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. www.planet-pharma.com Please click ‘apply’ or contact Harry Banks at Planet Pharma for more information: E: [email protected]