Safety & PV Specialist I (Japanese Language Expert)

Safety & Pharmacovigilance Specialist I Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and the patient. We continuously seek ways to simplify and streamline our work to make Syneos Health and us easier to work with and for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives. Why Syneos Health We are passionate about developing our people through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and a total rewards program. We are committed to our Total Self culture, where you can authentically be yourself. This culture unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. When we bring together a diversity of thoughts, backgrounds, cultures, and perspectives, we're able to create a place where everyone feels like they belong. Job Responsibilities Enter information into PVG quality and tracking systems for receipt and tracking of ICSR as required. Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. Triages ICSRs and evaluates ICSR data for completeness, accuracy, and regulatory reportability. Enters data into the safety database. Codes events, medical history, concomitant medications, and tests. Compiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Assists in generating timely, consistent, and accurate reporting of expedited reports following applicable regulatory requirements. Maintains safety tracking for assigned activities. Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, and MedDRA coding as required. Validation and submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA. Manual recoding of unrecoded product and substance terms arises from ICSRs. Identification and management of duplicate ICSRs. Activities related to SPOR / IDMP. Quality review of ICSRs. Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans, and the drug development process. Fosters constructive and professional working relationships with all project team members, internal and external. Participates in audits as required/appropriate. Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.

Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.