Safety & PV Specialist I

As a Safety & PV Specialist I (Japanese Language Expert) at Syneos Health, you will play a crucial role in ensuring the safety of patients by handling and processing Individual Case Safety Reports (ICSRs) in compliance with regulatory requirements. Your responsibilities will include: - Entering information into PVG quality and tracking systems for ICSRs receipt and tracking - Assisting in processing ICSRs according to SOPs and safety plans - Triaging ICSRs, evaluating data for completeness and accuracy - Entering data into safety database, coding events, medical history, medications, and tests - Compiling complete narrative summaries and identifying information to be queried - Generating expedited reports in accordance with regulatory requirements - Performing literature screening and review, drug coding, and maintenance of drug dictionary - Validating and submitting xEVMPD product records and managing duplicate ICSRs - Participating in activities related to SPOR / IDMP and ensuring compliance with regulations and guidelines Your qualifications for this role include a background in pharmaceutical safety reporting, familiarity with global regulations, and the ability to maintain compliance with SOPs and guidelines. By joining Syneos Health, you will be part of a company dedicated to employee development, diversity, and creating a supportive work environment where everyone can thrive. Syneos Health is a leading biopharmaceutical solutions organization committed to accelerating customer success and making a positive impact on patient lives. With a global presence and a focus on innovation, we offer a dynamic and collaborative work environment where your contributions will be valued and recognized. Discover the opportunities at Syneos Health and be a part of our mission to drive positive change in the healthcare industry.,