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Syneos Health

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3.8

based on 594 Reviews

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3 Syneos Health Japanese Language Expert Jobs

Japanese Language Expert Safety & PV Specialist

Syneos Health

 · 

3.8

 based on 594 Reviews

2-6 years

Kolkata, Mumbai, New Delhi + 4 more

1 vacancy

Japanese Language Expert Safety & PV Specialist

Syneos Health

posted 28d ago

Job Role Insights

Flexible timing

Key skills for the job

Supervision Excel Communication Skills MedDRA Presentation Skills

Job Description

  • 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
  • Qualifications
  • 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%)

    • Employment Type: Full Time, Permanent

    Read full job description

    Prepare for Japanese Language Expert roles with real interview advice

    What Japanese Language Expert at Syneos Health are saying

    Japanese Language Expert salary at Syneos Health

    reported by 4 employees with 1-3 years exp.
    ₹4.7 L/yr - ₹7.2 L/yr
    7% less than the average Japanese Language Expert Salary in India
    View more details

    What Syneos Health employees are saying about work life

    based on 594 employees
    81%
    97%
    89%
    96%
    Flexible timing
    Monday to Friday
    No travel
    Day Shift
    View more insights

    Syneos Health Benefits

    Submitted by Company
    Financial Health
    Learning, Development and Growth
    Physical Health
    Employee Resources
    Submitted by Employees
    Work From Home
    Health Insurance
    Job Training
    Soft Skill Training
    Cafeteria
    Team Outings +6 more
    View more benefits

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