Japanese Language Expert Safety & PV Specialist

• Coordinates workflow to ensure delivery of project
• May be responsible for distributing and monitoring team workload
• Escalates issues with project deliverables, finance and quality to Safety Program Delivery Lead/Manager or Line Manager as appropriate in a timely manner
• Provides support to manage safety and pharmacovigilance project risks/ issues as required
• Understands financial measures, work orders, performance metrics (including quality parameters, monthly budget reports, and changes in scope) and project budgets
• Assists in the preparation of project plans such as Safety Management Plan
• Assists in the preparation and participates in internal project review meetings as required
• May perform set-up, delivery, and close-out of safety and pharmacovigilance projects
• Maintains safety tracking for assigned activities
• May enter information into SPVG quality and tracking systems for receipt and tracking ICSR
• May process ICSRs according to Standard Operating Procedures (SOPs) and project/programspecific safety plans
• Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability
• Enters data into safety database
• Codes events, medical history, concomitant medications, and tests
• Compiles complete narrative summaries
• Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved
• Participates in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements
• Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases
• May perform or participate in quality control of literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding
• 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
• Quality review for the work performed by peers
• Serves as a subject matter expert in SPVG, which includes resolution of project related routine queries, mentoring, and coaching
• Managing a small team within the project
• Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports
• Provides training of Investigators on ICSR reporting or training to project team members for appropriate project related activities
• Participate in audits/inspections as required
• 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
• Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities

What were looking for

• Bachelors Degree in life science, registered nurse, pharmacist or an equivalent combination of education 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
• In depth 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), TeamShare (or other management/shared content/workspace) and internet
• Ability to work independently and in a team environment
• Strong communication, presentation, interpersonal skills, both written and spoken
• Strong 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
• Able to make effective decisions
• Minimal travel may be required (up to 10%)