Safety & PV Specialist I-Japanese

As a Safety & Pharmacovigilance Specialist I at Syneos Health, you will play a crucial role in ensuring the safety and well-being of patients involved in clinical trials and post-marketing programs. You will be responsible for entering information into PVG quality and tracking systems, processing ICSRs according to SOPs, and ensuring completeness and accuracy of ICSR data. Additionally, you will be involved in coding events, medical history, and conducting literature screening for safety. Key Responsibilities: - Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required - Assist in processing ICSRs according to SOPs and safety plans - Evaluate ICSR data for completeness, accuracy, and regulatory report ability - Enter data into safety database and compile narrative summaries - Code events, medical history, concomitant medications, and tests - Perform literature screening and review for safety - Maintain safety tracking for assigned activities - Ensure timely and accurate reporting of expedited reports - Maintain compliance with regulations and guidelines related to safety and pharmacovigilance Qualifications: - Bachelor's Degree in life science, registered nurse, pharmacist, or equivalent - Knowledge of safety database systems and medical terminology - Understanding of clinical trial process, ICH GCP, GVP, and safety regulations - Proficiency in Microsoft Office Suite, email, and internet - Ability to work independently and in a team environment - Excellent communication and interpersonal skills - Strong organizational skills with the ability to prioritize tasks and meet deadlines Syneos Health is dedicated to developing its employees and creating a supportive work environment where diversity and inclusion are valued. Join us in our mission to accelerate customer success and make a difference in the lives of patients worldwide.,