Clinical Safety Coordinator

Planet Pharma are currently partnered with an exciting global medical device company, and we are actively seeking a Clinical Safety Coordinator to join the business fully remotely in Bulgaria. Key Responsibilities: Ensure that all the Clinical Study (Safety) reports are run, filtered & prepared as per Clinical Safety Management and Potential Complaint Plans (CSMPCP) Support with gathering and compiling information for reports required for potential complaint and regulatory reporting purposes Support reconciliation activities and run listings for data cleaning in line with study milestones Provide technical support, which may include training, documentation, data extraction, and tracking Provide metrics information by compiling information from various sources Manage per Good Documentation Practice (GDP) all Safety relevant Clinical Study files and oversee the workflow and distribution of clinical study documents Ensure that all the Clinical Safety records are filed in the Trial Master File Assists with periodic audits by ensuring that the applicable clinical study files are proved for completeness and accuracy Support Clinical Event Committee (CEC) preparation and post CEC meeting activities, when applicable Apply knowledge of and has experience in company operations to assist in the development, implementation and administration of program/system guidelines and procedures 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’ and let us know of your interest!