Safety & PV Specialist II (Japanese Language)

Safety & PV Specialist II (Japanese Language)

Role & responsibilities

• Review safety case information in the Argus database, ensuring consistency between English source data and Japanese entries, and translate relevant data into accurate high-quality Japanese for regulatory-compliant reporting.
• Prepare and write Japanese narratives for Japan's specific cases as required.
• Handle Japan domestic safety cases including data entry from Japanese source documents, in compliance with Japan- specific reporting standards.
• Perform work primarily focused on reading and writing Japanese including medical narrators unstructured database fields with minimal speaking requirements.
• Demonstrate strong Japanese language proficiency advance kanji knowledge and the ability to accurately interpret clinical and safety information
• Background or working knowledge in pharmacovigilance, drug safety, or medical/life sciences field will be considered an added advantage.
• Enter information into PVG quality and tracking systems for receipt and tracking 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, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into safety database. Codes events, medical history, concomitant medications, and testsCompiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• Maintains safety tracking for assigned activities.
• Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.
• Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
• Manual recoding of un-recoded 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.

Qualifications:

• Mandatory to have JLPT N3 certification, JLPT N2 certification preferred
• Candidates with PV experience are preferred
• Bachelors Degree in life science/ Non-life science background and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job.
• Safety Database systems and knowledge of medical terminology required.
• Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance.
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet.
• Ability to work independently and in a team environment.
• Excellent communication and interpersonal skills, both written and spoken.
• Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.
• Detail oriented with a high degree of accuracy and ability to meet deadlines.