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Syneos Health

Compare

3.8

based on 576 Reviews

35 Syneos Health Jobs

Japanese Language Expert Safety & PV Specialist

Syneos Health

3.8

based on 576 Reviews

2-6 years

Kolkata, Mumbai, New Delhi + 4 more

1 vacancy

Japanese Language Expert Safety & PV Specialist

Syneos Health

posted 5hr 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

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What people at Syneos Health are saying

Japanese Language Expert salary at Syneos Health

reported by 5 employees with 1-3 years exp.

₹7.2 L/yr - ₹9 L/yr

13% more than the average Japanese Language Expert Salary in India

View more details

What Syneos Health employees are saying about work life

based on 576 employees

82%

95%

89%

96%

Flexible timing

Monday to Friday

No travel

Day Shift

View more insights

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