- working on Clinical Research field for over 5 years; - great experience in the domains:pediatrics, oncology, cardiology, infectious diseases and psychiatry; -I have done various trainings (SOPs) in the field of clinical studies, as well as in the field of pharmacovigilance; -- Processes and evaluates adverse event and medication error reports from health care providers and public in timely manner; - Assesses case reports in respect of: Quality of documentation, Causality Assessment, Clinical Relevance and Quality Control , in particular to identification of duplicate reports; - Communication of relevant safety Information to national and regional regulatory authorities, health professionals, pharmaceutical companies and other players as appropriate; - Ensures adherence to timelines; - Distributes safety information for clinical trial; - conducting from pre-selection visits to close out visits to investigator sites; - Involvement in administrative submissions; - Monitoring Studies - comparing CRF (Case Reporting Form) with Observation Sheet (SDF); compliance with protocol / evidence of study materials; - Compiling the Sponsor & Investigator file; - Compliance with the rules of good clinical practice and internal working procedures; - Collecting case reporting forms and sending them to Data Management; - Translation of study documents; - Monitoring and reporting situations regarding the status of clinical trials; - Permanent communication with study sites: providing regular telephone communications, informing sites about the evolution / status of the study; - analytical thinking - counselling the Investigators - focus on results - searching for and collecting information - stress management - motivation - troubleshooting - strategic perspective - analyse - synthesis - monitoring - planning